Overview | zoledronic acid (zoledronic acid) is the third generation of bisphosphonic acid anti-osteoporosis drugs, mainly used for the treatment of osteoporosis, hypercalcemia and bone-related diseases caused by malignant tumors. Zoledronic acid as a new class of bisphosphonic acid drugs, which contains two phosphonic acid groups, the compound is very polar, zoledronic acid impurity is an intermediate in the synthesis process of zoledronic acid, easy to be introduced into the injection products. However, at present, the related substances are not determined in the high performance liquid phase detection method for Aclasta (Zoledronic acid Injection) and zoledronic acid impurities, and there are obvious defects in the control of product quality. |
Application | zoledronic acid impurity is a pharmaceutical intermediate, which is mainly used as an impurity control in the process of pharmaceutical research and development, and can be used as a standard reference substance analysis. |
detection method | a method for the determination of zoledronic acid impurities in Aclasta (Zoledronic acid Injection) by high performance liquid chromatography, which comprises the following steps, take Aclasta (Zoledronic acid Injection) as the test sample; B. Take the reference of zoledronic acid impurity and dissolve it with diluent to obtain the reference solution; c. Use the following chromatographic conditions to test the test sample and the reference solution respectively: stationary phase: silica gel bonded with eighteen alkyl silane as filler; Mobile phase: disodium hydrogen phosphate mixed solution: methanol: acetonitrile volume ratio of 90~95:6~3:4~2; Wherein, the mixed solution of disodium hydrogen phosphate is composed of the following components by mass percentage: 13-14% of disodium hydrogen phosphate, 0.4-0.5% of tetrahexylammonium hydrogen sulfate, and the balance is water, and the pH value is adjusted to 7.7-8.0; detection wavelength: 200 ~ 225nm. |