RP-HPLC法测定人工牛黄甲硝唑胶囊中甲硝唑的溶出度

摘要

目的：建立RP-HPLC法对人工牛黄甲硝唑胶囊中甲硝唑溶出度的测定方法。方法采用C18色谱柱，甲醇-水（20∶80）为流动相，流速：1.0mL/min，检测波长320nm，柱温35℃。结果甲硝唑进样量在0.4～4.0μg范围内呈良好线性关系，r=0.9999，平均回收率为99.45％，RSD为0.46％（n=6）；3批次样品溶出度检查结果良好。结论本法简单、准确、重现性高、专属性强，符合溶出度方法的建立原则，可用于人工牛黄甲硝唑胶囊中甲硝唑溶出度的测定。%Objective To establish an RP-HPLC method for the determination on dissolution rate of metronidazole ingalculus bovis and metronidazole capsules.MethodsC18 column was used with a mobile phase composed of methanol-water(20:80)at a flow rate of 1.0 mL/min. The detection wavelength was 320nm and the temperature of column was 35℃. Results Metronidazole presented a good linear correlation with in the range of 0.4-4.0μg,r=0.9999. The averange recovery was 99.45%,with RSD of 0.46%(n=6); Three batches of sample dissolution test results are good. Conclusion This method is simple,accurate with good reproducibility,specificity ,and can be used in the quality cancrol of dissolution rate in galculus bovis and metronidazole capsules.