论文部分内容阅读
目的:考察市售3个厂家滴眼用利福平配制后不同条件下的稳定性。方法:采用HPLC法,使用Shimpack Vp-ODS色谱柱(4.6 mm×150 mm,5μm),以甲醇-乙腈-0.075 mol·L-1磷酸二氢钾溶液-1.0 mol·L-1枸橼酸溶液(30∶30∶26∶4)为流动相,流速1.0 m L·min-1,柱温为室温,检测波长254 nm。按外标法以峰面积计算含量。不同厂家滴眼用利福平配制后在室温避光、避光冷藏2种贮存条件下,0、1、3、7、14、28 d利福平的含量。结果:3厂家滴眼用利福平配制后稳定性存在差别,滴眼用利福平在避光冷藏下稳定性较好,但14 d后,3厂家利福平含量均下降超过5%。结论:配制好的利福平滴眼液应低温、避光保存,生产厂家应标注配制后的使用时限。
OBJECTIVE: To investigate the stability under different conditions after the three manufacturers marketed with Rifampicin. Methods: HPLC-MS method was applied on Shimpack Vp-ODS column (4.6 mm × 150 mm, 5 μm) with methanol-acetonitrile-0.075 mol·L-1 potassium dihydrogen phosphate solution-1.0 mol·L-1 citric acid solution (30:30:26:4) as the mobile phase at a flow rate of 1.0 m L · min-1. The column temperature was at room temperature and the detection wavelength was 254 nm. According to external standard method to calculate the peak area. Different manufacturers eye drops with rifampin formulation at room temperature, dark, dark storage conditions, 0,1,3,7,14,28 d rifampin content. Results: There were differences in the stability of the 3 eye drops with rifampicin. The stability of the eye drop of rifampicin was better under light-cold storage, but the content of rifampin in 3 manufacturers all dropped by more than 5% after 14 days. Conclusion: The prepared rifampicin eye drops should be low temperature, dark storage, the manufacturer should be marked after the preparation of the use of time.