HPLC法测定复方二甲双胍格列吡嗪胶囊的含量均匀度

Improvement of the Content Determination in Quality Standard of Glipizade Metformin Hydrochloride Capsules

目的:建立高效液相色谱法测定复方二甲双胍格列吡嗪胶囊中格列吡嗪的含量均匀度,为胶囊中格列吡嗪含量均匀度质量标准提高提供可靠实验依据与技术支持。方法:采用高效液相色谱法,十八烷基硅烷键合硅胶色谱柱;流动相为磷酸盐缓冲液-甲醇(45︰55),检测波长225nm。结果:格列吡嗪在19.97~29.96μg/mL范围内呈良好的线性关系,回归方程Y=62193X+46178(R~2=0.9994),方法回收率在99.02%~100.80%之间(RSD为0.58%),3批样品的格列吡嗪含量均匀度测定结果符合《中国药典》四部通则规定;结论:该方法测定格列吡嗪含量均匀度专属性强,准确度与精密度均良好,可以用于胶囊中格列吡嗪含量均匀度的测定,并为推动该品种药品质量标准的提升提供了十分重要的理论与实践意义。

Objective: To establish a method for determination of the content uniformity in glipizade metformin hydrochloride capsules by HPLC, so as to provide reliable technical support for improving quality inspection standard. Methods: The test was performed in C18 column with potassium phosphate and methanol as mobile phase(45︰55), the detection wavelength was 225nm. Results: The linear range fell into 19.97~29.96 μg/mL, the calibration equation was Y =62193X + 46178(R~2=0.9994), and the average recovery was between 99.02 %~100.80 % with RSD as 0.58 % for glipizide. The uniformity of content of glipizide in 3 batches samples were consistent with regulation. Conclusion: This estabilished method is simple and accurate. It can be used for determination of the content uniformity in glipizade metformin hydrochloride capsules, and it has very important theoretical and practical significance for promoting the quality standards.