Method for detecting calcitriol soft capsule related substances by adopting double ternary

Abstract

The invention relates to the technical field of medicines, in particular to a determination method for detecting calcitriol soft capsule related substances. The name of the invention is a method for detecting the calcitriol soft capsule related substances by using a double ternary high performance liquid chromatography. The method comprises the steps of performing determination by adopting a highperformance liquid chromatography analyzer, respectively determining the peak areas of a test sample and a control sample, and calculating the content of related substances in the sample by using a self-control method. According to the method, the sensitivity of sample determination is improved, 0.01% of impurities can be detected, known impurities and unknown impurities can be effectively controlled, the accuracy is obviously improved, the operation is simple and sensitive, the durability is good, reliable related substance data are provided for drug detection, and the quality of drugs is better controlled.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a method for detecting related substances in calcitriol soft capsules. Background technique [0002] The critical role of calcitriol in the regulation of calcium homeostasis, including stimulation of osteoblast activity in bone, provides an adequate pharmacological basis for the treatment of osteoporosis. Suitable for postmenopausal osteoporosis; chronic renal insufficiency; postoperative hypothyroidism; idiopathic hypoparathyroidism; pseudohypothyroidism; vitamin D-dependent rickets; hypophosphatemic vitamin D-resistant rickets, etc. . [0003] The specifications of calcitriol soft capsules are 0.5ug and 0.25ug. At present, there are high-performance liquid phase method and LC-MS-MS method for the determination of related substances in domestic and foreign literatures. Among them, the sensitivity of high-performance liquid phase method is too low, and the lowest can only det...

AI Technical Summary

Problems solved by technology

At present, there are high-performance liquid phase method and LC-MS-MS method for the determination of related substances in domestic and foreign literatures. Among them, the sensitivity of high-performance liquid phase method is too low, and the lowest can only detect about 1% of impurities, and cannot effectively detect related substances. LC-MSMS method can only measure the content of known impurities, and the required impurity reference substance is not easy to obtain, and cannot effectively measure unknown impurities

At present, there is no simple, efficient and accurate method for the determination of related substances in calcitriol soft capsules

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