复方岩白菜素片中马来酸氯苯那敏的含量及含量均匀度HPLC方法的建立和研究

Determination of Chlorphenamine Maleate and Its Content Uniformity in Compound Bergeninum Tablets by HPLC

目的:建立了复方岩白菜素片中马来酸氯苯那敏含量及含量均匀度测定的HPLC方法。方法:采用辛烷基硅烷键合硅胶为填充剂,柱温30℃,流速1.0 mL∙min−1,以甲醇-1%醋酸(二乙胺调节pH至3.7) (50:50)为流动相,检测波长为262 nm。结果:马来酸氯苯那敏的线性范围为0.0104~0.0833 mg∙min−1 (r = 0.9995);平均回收率为99.9% (RSD为1.0%,n = 9);十二批次样品马来酸氯苯那敏含量在92.1%~100.7%,含量均匀度值(A + 2.2 S)在3.2~13.5。结论:经方法学验证,该方法准确,专属性强,重现性好,适用性广,可用于复方岩白菜素片中马来酸氯苯那敏的含量及含量均匀度的检测。

OBJECTIVE: To establish an HPLC method for the determination of chlorphenamine maleate and its content uniformity in compound bergeninum tablets. METHODS: The C8 column was adopted at the flow rate of 1.0 mL∙min−1 with the column temperature of 30˚C. The mobile phase was methanol-1% acetic acid (adjust pH to 3.7 with diethylamine) (50:50). The detection wavelength was 262 nm. RESULTS: The analytes had a good linear relation in the range of 0.0104 - 0.0833 mg∙mL−1, r = 0.9995. The average recovery was 99.9% (RSD = 1.0%, n = 9);the contents of chlorphenamine maleate in samples of twelve batches were 92.1% - 100.7%. The content uniformity (A + 2.2 S) of these samples were 3.2 - 13.5. CONCLUSION: The method was accurate, reliable and has good specificity, suitable for the determination of chlorphenamine maleate and its content uniformity in compound bergeninum tablets.