艾司唑仑片溶出度检测方法的建立以及溶出曲线评价

目的: 建立艾司唑仑片溶出度HPLC检测方法及进行溶出曲线评价。 方法: 采用Waters C₁₈(150 mm×4.6 mm,3 μm)色谱柱,以乙腈-水(40∶60)为流动相,流速1 mL·min^-1,检测波长223 nm;溶出度试验采用桨法,以水为溶出介质,转速50 r·min^-1。 结果: 在本文色谱条件下,艾司唑仑浓度在0.05~1.2 μg·mL^-1的检测范围内线性良好,色谱方法较好地对艾司唑仑溶出量进行了检测;溶出方法合适,较好地反映了不同厂家不同批次间艾司唑仑溶出行为的差异。 结论: 所建立的色谱条件简单方便,提高了溶出量检测专属性和准确性,改善后的溶出方法较好地体现了片剂间的差异。

Objective: To establish an HPLC method for the determination of the dissolution of estazolam tablets and evaluate the dissolution curve. Methods: The chromatographic column was Waters C₁₈ (150 mm×4.6 mm,3 μm),the mobile phase consisted of 40% acetonitrile and 60% water at the flow rate of 1 mL·min^-1,the detection wavelength was 223 nm.The paddle method was used for the dissolution test with water as the medium and the rotation rate was set at 50 r·min^-1. Results: Under the chromatographic condition in this study,there was a good linear relationship in the range of 0.05-1.2 μg·ml^-1 for estazolam,indicating that the chromatographic method detected well.The dissolution method was suitable,showing differences of dissolutions among products of different lots and different manufacturers. Conclusion: This HPLC method is simple,accurate and specific for determination of dissolution.The improved dissolution method is more discriminating among different tablets than before.

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