Drug impurity detection method based on tenofovir alafenamide fumarate tablets

Abstract

The invention relates to a drug impurity detection method based on tenofovir alafenamide fumarate tablets, comprising, step S1, preparing a solution to be tested, the solution to be tested includes a sensitivity solution, a control solution, a system adaptability solution and a sample solution; Step S2, start the detection system to detect the content of each component in the solution to be tested. If the sensitivity of the current detection system does not meet the preset standard, the central control unit will store the last detection result in the information storage module to perform a test on the gradients of each stage set in the detection system. Adjust the phase content and elution time, start the cleaning device installed in the chromatography column, and the central control unit obtains the cleaning frequency to clean the chromatography column according to the last detection result stored in the information storage module; step S3, the central control unit cleans the chromatography column according to the Measure the chromatogram of the solution to obtain the amount of each impurity in tenofovir alafenamide fumarate tablets. Among them, the central control unit compares the amount of each impurity with the preset amount of impurities to determine the quality of the current tenofovir alafenamide fumarate tablet. Make a judgment.

Description

Detection method of drug impurities based on tenofovir fumarate tablets technical field The present invention relates to the field of pharmaceutical impurities, in particular to a kind of pharmaceutical impurities based on tenofovir fumarate alafenamide tablets Detection method. Background technique About 2 billion people in the world of hepatitis B patients, about 330,000 people die of liver cirrhosis and primary liver cancer caused by hepatitis B every year, my country ranks in the top three. Tenofovir alafenamide fumarate (TAF) is an antiviral treatment for chronic hepatitis B in adults and adolescents A powerful drug, it belongs to the same nucleoside (acid) class as tenofovir disoproxil fumarate (TDF) and entecavir (ETV), and ranks among the global The three first-line drugs in the hepatitis B treatment guidelines. At present, the new anti-hepatitis B drug tenofovir fumarate developed by Gilead in the United States (TAF) is more targeted than tenofovir disop...

AI Technical Summary

Problems solved by technology

[0004] For this reason, the present invention provides a drug impurity detection method based on tenofovir alafenamide fumarate tablets, which can solve the technical problem that the quality of the drug cannot be obtained from the detection results of each impurity in the drug according to the sensitivity of the detection system

Images