酒石酸氢可酮片溶出度测定的方法学验证

Tartaric Acid Hydrocodone Methodology Validation for the Determination of Dissolution

目的：对酒石酸氢可酮片的溶出度检查进行方法学验证．方法：参照《中国药典》（2010年版二部附录XC 第二法）对其溶出度进行检查．采用高效液相法，计算每片的溶出量，进行方法学验证．结果：以酒石酸氢可酮对照品浓度（μg／mL）为横坐标、峰面积为纵坐标，绘制标准曲线，并对测得的数据进行回归分析，酒石酸氢可酮浓度在2．04～20．40μg／m L 范围内与峰面积呈良好的线性关系．取酒石酸氢可酮片进行精密度试验、干扰性试验、稳定性试验、重复性试验、回收率试验、溶出度均一性试验（批内）、滤膜吸附的验证、检测限及定量限的测定均符合要求．结论：方法学研究结果表明，用本方法可以真实、有效、准确的测定酒石酸氢可酮片的溶出量，故本方法可行，可用于该产品的质量控制．

The purpose of tartaric acid hydrocodone verifies the methodology of dissolution test .Meth‐ods with reference to the Chinese pharmacopoeia 2010 edition method appendix XC second part two ） in‐spection on its dissolution .Using HPLC method ,calculate the dissolubility of each piece ,verified method‐ology .The results of With tartaric acid hydrocodone reference substance concentration （including g/ml） as the abscissa ,peak area as the ordinate ,draw the standard curve ,and the measured data regression analy‐sis ,the concentration of tartaric acid hydrocodone within 2 .04~20 .40 （including g/ml had good linear re‐lationship with the peak area .Taking tartaric acid hydrocodone precision experiment ,interference test , stability test ,repeatability test ,recovery rate test ,dissolution uniformity test （group） ,a membrane ad‐sorption of validation ,the determination of the lod and loq of conform to the requirements .Conclusion methodology research results show that this method can be true ,effective and accurate determination of the dissolubility of tartaric acid hydrocodone ,this method is feasible ,and can be used for the quality con‐trol of products .