3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE
Glimepiride
CAS: 93479-97-1
Molecular Formula: C24H34N4O5S
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Names and Identifiers
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Physico-chemical Properties
| Molecular Formula | C24H34N4O5S |
| Molar Mass | 490.62 |
| Density | 1.29±0.1 g/cm3(Predicted) |
| Melting Point | 212.2-214.5 °C |
| Boling Point | 677.0±65.0 °C at 760 mmHg |
| Water Solubility | DMSO: >10 mg/mL |
| Solubility | Soluble in DMSO (>10 mg/ml), water (<1 mg/ml at 25 °C), and ethanol (<1 mg/ml at 25 |
| Appearance | White crystal solid |
| Color | white |
| Merck | 14,4440 |
| pKa | 5.10±0.10(Predicted) |
| Storage Condition | room temp |
| Refractive Index | 1.599 |
| MDL | MFCD00878417 |
| Physical and Chemical Properties | Melting Point 212-214°C |
| Use | Used as a hypoglycemic agent |
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Risk and Safety
| Risk Codes | R21 - Harmful in contact with skin R36/38 - Irritating to eyes and skin. R46 - May cause heritable genetic damage R62 - Possible risk of impaired fertility R63 - Possible risk of harm to the unborn child |
| Safety Description | S25 - Avoid contact with eyes. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - obtain special instructions before use. |
| WGK Germany | 3 |
| RTECS | UX9363950 |
| HS Code | 2935904000 |
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Reference
| Reference Show more | 1. Cui Haiyue, fan Siqi, Li Yufang, Liu Ying, Liu Tao. Clinical observation of mesoporous carbon nanoparticles in improving the hypoglycemic effect of glimepiride [J]. Journal of Jinzhou Medical University, 2020,41(06):15-19. |
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Nature
Open Data Verified Data
melting point 207 °c.
Last Update：2024-01-02 23:10:35
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Preparation Method
Open Data Verified Data
3-ethyl -2,5-= hydrogen -4-methyl -2-oxygen -1H-pyrrole and phenylethyl isocyanate reaction, then chlorosulfonic acid chlorosulfonation, ammonolysis for sulfonamide, finally, the product is obtained by condensation with P-methylcyclohexyl isocyanate.
Last Update：2022-01-01 09:24:01
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Standard
Authoritative Data Verified Data
This product is 1-[[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-formylamino)] ethyl] phenyl] sulfonyl]-3-(trans-4-methylcyclohexyl) urea. The content of C24H34N405S shall be 98.0% ~ 102.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder; Odorless.
- This product is dissolved in chloroform, very slightly dissolved in ethanol, in water or 0.lmol / L hydrochloric acid solution is almost insoluble; In 0. Very slightly dissolved in lmol / L sodium hydroxide solution.
Last Update：2022-01-01 15:36:09
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Use
Open Data Verified Data
Hoeehst Marion Rousel was developed and launched in 1995. The product is the third generation of sulfonylurea long-acting anti-diabetic drugs. For simple diet control and exercise failed to control blood sugar in patients with type II diabetes.
Last Update：2022-01-01 09:24:01
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Differential diagnosis
Authoritative Data Verified Data
- take this product, dissolve and dilute with ethanol to make a solution containing about lOug per lml, and measure it by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 228nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1085).
- take this product about 0.lg and 0.2g of potassium nitrate were mixed, heated to oxidize after carbonization, and allowed to cool. The residue was dissolved by adding 10ml of water, filtered, and the filtrate was identified as sulfate (General rule 0301).
Last Update：2022-01-01 15:36:10
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Exam
Authoritative Data Verified Data
chloride
take this product l. Add 50ml of water, boil, cool quickly, filter, add water to make the filtrate into 50ml, take 25ml, check according to law (General rule 0801), not more concentrated (7.0) than a control solution made of 0.014% of standard sodium chloride solution.
sulfate
take 0.5g of this product, add 25ml of water, boil, quickly cool, filter, filtrate add water to make 25ml, check according to law (General rule 0802), and standard potassium sulfate solution 2.0 ml of the control solution should not be more concentrated (0.040%).
cyanide
take this product 0.5g, inspection according to law (General Principles 0806 The first law), should comply with the provisions.
Related substances
take an appropriate amount of this product, precision weighing, add 80% acetonitrile solution to dissolve and dilute to make a solution containing 0.20mg per 1ml as a test solution; Take 1ml for precision measurement, dilute to the scale with 80% acetonitrile solution in a 80% measuring flask, shake well, and use as a control solution; Precisely measure 1ml of the control solution, place it in a 20ml measuring flask, and dilute to the scale with acetonitrile solution, shake well as a sensitivity solution. According to the chromatographic conditions under the content determination item, the sensitivity solution is injected into the liquid chromatograph, and the chromatogram is recorded. The signal-to-noise ratio of glimepiride peak should not be less than 10. 20ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention times of the peaks of impurities I and II, the peak area shall not be greater than 0.1 times (0.1%) of the main peak area of the control solution; if there are chromatographic peaks with the same retention time as the impurity III peak, the peak area shall not be greater than 0.77 times (0.4) of the main peak area of the control solution after multiplying the correction factor by 0.4%; if there is a chromatographic peak with the same retention time as the impurity IV peak, the peak area shall not be greater than 0.2 times (0.2%) of the main peak area of the control solution; other single impurity peak area shall not be greater than 0.1 times (0.1%) of the main peak area of the control solution; Except for impurity III, the sum of impurity peak areas shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution. The peak in the test solution chromatogram which is smaller than the main component peak area in the sensitivity solution chromatogram is negligible (0.05%).
cis isomer (impurity V )
take about 12.5mg of this product, accurately weigh, put it in a 25ml measuring flask, add 6mL of dichloromethane, shake to dissolve, dilute to the scale with mobile phase, shake well, as a test solution; Take 1ml of precision measurement, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as a control solution; Take another cis-isomer (impurity V). About 5m g of the reference substance, put it in a 25ml measuring flask, add 5ml of dichloromethane, shake to dissolve it, dilute it with mobile phase to the scale, shake well, take 0.2 and put it in a 10ml measuring flask, dilute to the scale with the test solution as a system-suitable solution. According to the high performance liquid chromatography (General 0512) test, using dihydroxypropane bonded silica gel as filler (Macherey-Nagel 100-5 OH column, 4.6mm X 250mm or equivalent separation efficiency column), N-heptane-anhydrous ethanol-glacial acetic acid (900:100:1) was used as mobile phase, and the detection wavelength was at 228nm. Take the system applicable solution lOul, inject into the liquid chromatograph, adjust the flow rate so that the retention time of glimepiride peak is about 21 minutes, the relative retention time of cis isomer peak is about 0.9, the resolution of the CIS-isomer peak from the glimepiride peak should be satisfactory. 10ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the cis isomer (impurity V) in the chromatogram of the system applicable solution, the peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 15:36:11
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane was used as a filler; Acetonitrile-0.1% sodium dihydrogen phosphate solution (adjusted to pH 3.0 0.5 with phosphoric acid) (50:50) was used as a mobile phase, and the detection wavelength was at 228nm. Glimepiride impurities I, II, III, IV of each appropriate amount, respectively, plus 80% acetonitrile solution dissolved and quantitatively diluted to prepare each 1 ml containing 100ug of the solution, as impurities I, stock solutions of II, III and IV reference substances; Additional glimepiride reference substances, about 20mg, were precision weighed and placed in a 100ml measuring flask, add 80% acetonitrile solution to dissolve and dilute to the scale, shake, as the system applicable solution. 20ul of the applicable solution of the system is injected into the liquid chromatograph, and the chromatogram is recorded. The peak sequence is impurity III, impurity II, impurity I, glimepiride and impurity IV. The number of theoretical plates shall not be less than 2000 calculated by glimepiride peak, and the separation degree between glimepiride peak and impurity peaks shall meet the requirements.
assay
take about 10 mg of this product, weigh it accurately, put it in a 50ml measuring flask, add an appropriate amount of 80% acetonitrile solution, ultrasonic to dissolve, let it cool, dilute it to the scale with 80% acetonitrile solution, shake well, take 5ml accurately, put it in a 25ml measuring flask, dilute it to the scale with 80% acetonitrile solution, shake well, take 10ul accurately, inject it into liquid chromatograph, record chromatogram; an appropriate amount of glimepiride reference substance was added, and 80% acetonitrile solution was added to dissolve and quantitatively dilute to prepare a solution containing 40ug per lml, and the same method was used for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:36:12
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Category
Authoritative Data Verified Data
hypoglycemic drugs.
Last Update：2022-01-01 15:36:12
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Storage
Authoritative Data Verified Data
sealed and stored in a cool place.
Last Update：2022-01-01 15:36:12
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Glimepiride tablets
Authoritative Data Verified Data
This product contains glimepiride (C24H34N405S) should be 90.0% to 110.0% of the label.
trait
This product is a white piece or a colored abnormal piece.
identification
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of fine powder of this product (about 1 mg of glimepiride), put it in a 100ml measuring flask, add an appropriate amount of ethanol, ultrasonic dissolve glimepiride, dilute it to the scale with ethanol, shake well, filter, the filtrate was measured by UV-Vis spectrophotometry (General 0401), and had a maximum absorption at a wavelength of Nm.
examination
- relevant substances: take an appropriate amount of fine powder of this product (about 2mg of glimepiride), put it in a 10ml measuring flask, and add an appropriate amount of 80% acetonitrile solution. Sonicate the glimepiride to dissolve and cool, dilute with 80% acetonitrile solution to the scale, shake, filter, and take the filtrate as the test solution. Take 1ml of precision measurement, put it in a 100ml measuring flask, and dilute with 80% acetonitrile solution to the scale, shake, as a control solution; Precision take the control solution 1ml, 20ml flask, diluted with 80% acetonitrile solution to the scale, shake, as a sensitivity solution. According to the chromatographic conditions under the content determination item, take the sensitivity solution 20 u1, inject into the liquid chromatograph, record the chromatogram, glimepiride peak signal to noise ratio should be not less than 10. 10ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the impurity DI peak, the peak area multiplied by the correction factor of 0.77 shall not be greater than the main peak area of the control solution (1.0%) the Peak area of other individual impurities shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (1.0%). The peak in the test solution chromatogram which is smaller than the main component peak area in the sensitivity solution chromatogram is negligible (0.05%).
- Content uniformity take 1 tablet of this product, put it in a 25ml ( lmg specification) or 50ml(2mg specification) measuring flask, add water 1~2ml, ultrasonic to disintegrate, add an appropriate amount of 80% acetonitrile solution, ultrasonically dissolve glimepiride, allow to cool, dilute to the scale with 80% acetonitrile solution, shake well, filter, take the continued filtrate as the test solution, and determine the content according to the method under the content determination item, the provisions shall be met (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), phosphate buffer solution (take potassium dihydrogen phosphate 22.34g and disodium hydrogen phosphate g, add water 1000ml, shake to dissolve, use 10% phosphoric acid solution or 1 mol / L sodium hydroxide solution to adjust the pH value to 7.80±0.05 )900ml as the dissolution medium, the rotation speed is 75 rpm, operate according to law, after 15 minutes, take 5ml of the solution, filter, and take the filtrate as the test solution; Take about 10mg of glimepiride reference substance, weigh it accurately, put it in a 100ml measuring flask, add an appropriate amount of acetonitrile to dissolve and dilute to the scale, shake well; Take 1ml accurately, put 200ml (1 mg specification) or 100ml(2mg specification) measuring flask, dilute to scale with dissolution medium, shake well, as a reference solution. The dissolution amount of each tablet was calculated as measured by the method under the content measurement item. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-0.1% sodium dihydrogen phosphate solution (pH adjusted to 3.0 0.5 with phosphoric acid)(50:50) mobile phase; The detection wavelength was 228nm. Glimepiride impurity I, impurity II and impurity III were dissolved in 80% acetonitrile solution and diluted to prepare a solution containing about 20ug each in 1ml as a stock solution of impurity control. Another 10mg glimepiride reference was added to a measuring flask, and 1ml of impurity reference stock solution was added. Dilute with 80% acetonitrile solution to the mark, shake well, and use as system applicable solution, injected into the liquid chromatograph, the chromatogram was recorded, and the order of peaks was impurity III, impurity II, impurity I and glimepiride. The number of theoretical plate shall not be less than 2000 according to glimepiride peak, and the separation degree between glimepiride peak and impurity peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing fine powder (about equivalent to 10 mg of glimepiride), put 50ml measuring flask, add 80% acetonitrile solution, ultrasonic dissolution of glimepiride, cool, dilute to the scale with 80% acetonitrile solution, shake well, filter, Take 5ml of the filtrate and put it in a 25ml measuring flask, dilute with 80% acetonitrile solution to the scale, shake, as the test solution, take 10 u1 with precision, inject into the liquid chromatograph, record the chromatogram; Take the appropriate amount of glimepiride reference, precision weigh, A solution containing 40ug per 1 ml was prepared by dissolving and quantitatively diluting 80% acetonitrile solution and determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as glimepiride.
specification
⑴ lmg (2) 2mg
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 15:36:13
3-ETHYL-2,5-DIHYDRO-4-METHYL-N-[2-[4-[[[[(TRANS-4-METHYLCYCLOHEXYL)AMINO]CARBONYL]AMINO]SULFONYL]PHENYL]ETHYL]-2-OXO-1H-PYRROLE-1-CARBOXAMIDE - Glimepiride capsules
Authoritative Data Verified Data
This product contains glimepiride (C24H34N405S) should be 90.0% to 110.0% of the label.
trait
The content of this product is white powder.
identification
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of the content of this product (about 1 mg of glimepiride), put it in a 100ml measuring flask, add an appropriate amount of ethanol, ultrasonic dissolve glimepiride, dilute to the scale with ethanol, shake well, filter, the filtrate was measured by UV-Vis spectrophotometry (General 0401), and had a maximum absorption at a wavelength of Nm.
examination
- relevant substances: take an appropriate amount of the contents of this product (about 2mg of glimepiride), put it in a 10ml measuring flask, and add an appropriate amount of 80% acetonitrile solution. Sonicate the glimepiride to dissolve and cool, dilute with 80% acetonitrile solution to the scale, shake, filter, and take the filtrate as the test solution. Take 1ml of precision measurement, put it in a 100ml measuring flask, and dilute with 80% acetonitrile solution to the scale, shake, as a control solution; Precision take the control solution 1ml, 20ml flask, diluted with 80% acetonitrile solution to the scale, shake, as a sensitivity solution. According to the chromatographic conditions under the content determination item, take the sensitivity solution 20 u1, inject into the liquid chromatograph, record the chromatogram, glimepiride peak signal to noise ratio should be not less than 10. The LOLs of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity III peak, the peak area multiplied by the correction factor of 0.77 shall not be greater than the main peak area of the control solution (1.0%), other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than the main peak area of the control solution (1.0%). The peak in the test solution chromatogram which is smaller than the main component peak area in the sensitivity solution chromatogram is negligible (0.05%).
- Content uniformity take 1 capsule of this product, put it in a 50ml measuring flask, add 1~2ml of water, ultrasonic to disintegrate, add an appropriate amount of 80% acetonitrile solution, ultrasonic to dissolve glimepiride, let it cool, dilute with 80% acetonitrile solution to the scale, shake, filter, and take the filtrate as the test solution. Determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), phosphate buffer solution (take potassium dihydrogen phosphate 22.34g and disodium hydrogen phosphate g, add water 1000ml, shake to dissolve, with 10% phosphoric acid solution or 1 mol / L sodium hydroxide solution to adjust the pH value to 1.80±0.05 )900ml as the dissolution medium, the rotation speed is 75 rpm, according to the law, after 15 minutes, 5ml of the solution was filtered, and the filtrate was taken as the test solution. About 10mg of glimepiride reference substance was added, and then placed in a 100ml measuring flask, add an appropriate amount of acetonitrile to dissolve and quantitatively dilute to the scale, shake; Take 1ml accurately, put it in a 100ml measuring flask, dilute to the scale with dissolution medium, shake well, and use as a reference solution. The dissolution amount of each pellet was calculated as measured by the method under the content measurement item. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Acetonitrile-0.1% sodium dihydrogen phosphate solution (adjusted to pH 3.0±0.5 with phosphoric acid)(50:50) as mobile phase; the detection wavelength was 228nm. Appropriate amounts of glimepiride impurity I, impurity II and impurity III control were taken, and 80% acetonitrile solution was added to dissolve and dilute to prepare a solution containing each about 1ml as an impurity control stock solution. Another 10mg glimepiride reference was added to a measuring flask, and 1ml of impurity reference stock solution was added, diluted to the mark with 80% acetonitrile solution, and then shaken to obtain 10ul of the applicable solution for the system, injected into the liquid chromatograph, the chromatogram was recorded, and the order of peaks was impurity III, impurity II, impurity I and glimepiride. The number of theoretical plates shall not be less than 2000 calculated by glimepiride peak, and the separation degree between glimepiride peak and impurity peaks shall meet the requirements.
- determination Method: Take 20 capsules of this product, pour out the contents, accurately weigh the contents, grind the fine powder, accurately weigh an appropriate amount of fine powder (about 10 mg of glimepiride), and place it in a 50ml measuring flask, add an appropriate amount of 80% acetonitrile solution, sonicate glimepiride to dissolve, let it cool, dilute with 80% acetonitrile solution to the scale, shake well, filter, Take 5ml of filtrate accurately, put it in a 25ml measuring flask, dilute with 80% acetonitrile solution to the scale, shake, as a test solution, take lOul accurately, inject human liquid chromatograph, record the chromatogram; Take an appropriate amount of glimepiride reference, weigh accurately, 80% acetonitrile solution was added to dissolve and quantitatively diluted to prepare a solution containing about 40% per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is, get
category
Same as glimepiride.
specification
2mg
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 15:36:14
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