枸橼酸喷托维林片有关物质结果判定商榷

Discussion about Identification Criteria for Related Substances of Pentoxyverine Citrate Tablets

目的探讨枸橼酸喷托维林片有关物质的判定标准,为标准完善提供参考。方法采用《中国药典》2010年版规定的高效液相色谱法,测定枸橼酸喷托维林片的有关物质。结果与结论标准中枸橼酸喷托维林片有关物质判定描述不够严谨,给结果判定带来困难。建议修改为供试品溶液色谱图中如有杂质峰,除相对保留时间0.195倍左右的峰外,单个杂质峰面积不得大于对照溶液主峰面积(1.0%);各杂质峰面积的和不得大于对照溶液主峰面积的2.5倍。

Objective To discuss the identification criteria for the related substances of Pentoxyverine Citrate Tablets, and provide a reference for standard amendment. Methods The high-performance liquid chromatographic method described in Chinese Pharmacopeia 2010 edition was used to determine the related substances of Pentoxyverine Citrate Tablets. Results and Conclusion The identification criteria for the related substances of Pentoxyverine Citrate Tablets is not rigorous enough in quality standard, which brings difficulty to the determination. This study suggests to amend the criteria as follows： if there are impurity peaks in the test solution chromatogram, the area peak of single impurity should be no more than the main peak area of the reference solution （1.0%）, except the peak with a 0. 195-fold relative retention time; and the total area of each impurity peak should be no more than 2.5 times as much as the main peak area of the reference solution.