HPLC法同时测定复方炔雌醇甲羟孕酮胶囊中4种活性组分

Simultaneous determination of four bioactive components in compound methypregnone and ethinylestradiol capsules by HPLC

目的建立HPLC法同时测定复方炔雌醇甲羟孕酮胶囊中的淫羊藿苷、醋酸甲羟孕酮、维生素D2和维生素E。方法采用Thermo C18(150mm×4.6mm,5μm)色谱柱,乙腈-甲醇-水三元梯度洗脱,流速为1.0ml/min,进样量为10μl,检测波长为260nm。结果4种组分分别在2.89~28.86μg/ml、3.33~66.53μg/ml、0.29~2.87μg/ml和0.30~15.05mg/ml浓度范围内线性关系良好,平均回收率为96.8%~102.7%,相应的RSD为0.76%~2.43%。结论该方法快捷准确,灵敏度高,可代替原标准用于复方炔雌醇甲羟孕酮胶囊的质量控制。

Objective To develop an HPLC method for simultaneous determination of lcariin,nomegestrol acetate, v itamin D2 and vitamin E in compound methypregnone and ethinylestradiol capsules. Methods HPLC separations were carried out on a Thermo C18 column ( 150 mm × 4. 6 mm,5 μm) with a ternary gradient elution of methanol- acetonitrile-water at a flow rate of 1. 0 ml /min. The injection volume was 10 μl and the detection wavelength was 260 nm. Results Good linear relationships between the peak area and concentration were found in the ranges of 2. 89 ~ 28. 86 μg /ml, 3. 33 ~ 66. 53 μg /ml, 0. 29 ~ 2. 87 μg /ml and 0. 30 ~ 15. 05 mg /ml for 4 components, respectively. The average recoveries were in the ranges of 96. 8%~ 102. 7% with the RSD ranging from 0. 76% to 2. 43%. Conclusion The method is simple, accurate and sensitive. It can be used for the quality control of compound methypregnone and ethinylestradiol capsules instead of original standard.