A detecting method for improving tiopronin active pharmaceutical ingredient stability

Abstract

A detecting method for improving tiopronin active pharmaceutical ingredient stability is provided. The method includes a step of weighing a proper amount of tiopronin active pharmaceutical ingredient powder and adding a solvent to prepare a tiopronin solution having a tiopronin concentration of 1 mg / mL and adopted as a solution to be detected, a step of measuring the solution to be detected and adding the solvent to prepare a tiopronin solution having a tiopronin concentration of 0.01 mg / mL and adopted as a contrast solution, a step of measuring 10 muL of the contrast solution, injecting into a liquid chromatograph, and adjusting detection sensitivity to allow the peak height of a chromatographic peak of a main component to be 30% of the full scale of a recorder, and a step of measuring 10 muL of the solution to be detected, injecting into the liquid chromatograph, and recording until time is 4 times of the retention time of the main component peak, wherein the peak area of any purity is not more than 0.2 times of the area of a main peak of the contrast solution and the sum of peak areas of purities is not more than 1 time of the area of the main peak of the contrast solution so that the method is completed. Stability of the solution to be detected is ensured by adopting the method so that detection results of active pharmaceutical ingredient products are true and reproducible.

Description

technical field [0001] The present invention aims at the poor stability of the test solution in the related substance determination method of tiopronin raw material and tablet, the measurement result is inaccurate, and cannot really reflect the quality of the product, and provides a detection method for improving the stability of the tiopronin raw material drug method. Background technique [0002] Tiopronin Tablets is a drug declared and approved by the company, with the approval number H20065248 and the quality standard number YBH14632006. Tiopronin is a new type of glycine derivative containing free sulfhydryl groups. Clinical indications Viral hepatitis, alcoholic hepatitis, drug-induced hepatitis, heavy metal poisoning hepatitis, fatty liver and early liver cirrhosis; reduce the toxic and side effects of radiotherapy and chemotherapy, increase white blood cells and accelerate the recovery of liver cells, and reduce the rate of bone marrow chromosome aberration and the...

AI Technical Summary

Problems solved by technology

[0010] In the spectrum run under the modified system, it is obvious that the main component peaks are tailed (the tailing factor is 1.709). See the attached figure 1 Adjacent impurity can not be separated after the main component peak (the degree of separation is only 0.88), see attached figure 1 ; The applicability of the system is poor

[0011] The impurity control limit is unreasonable, only the total impurity is limited, there is no single impurity control limit

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