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目的建立异烟肼片体外溶出度HPLC检测方法及溶出曲线评价。方法溶出度试验采用桨法,转速50 r/min;以pH1.2盐酸缓冲液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液、水900 m L为溶出介质;HPLC法测定溶出量。结果异烟肼在0.198 1~0.990 4μg线性良好(r=0.999 3),平均回收率为100.2%;精密度、重复性、专属性均良好。在测定的16家企业中,有4家企业水中溶出曲线与参比制剂山德士异烟肼片不相似。结论 HPLC测定方法简单方便,提高了异烟肼溶出量测定的准确性和专属性;溶出方法具有较强的区分力,该溶出度测定方法可用于异烟肼片溶出曲线的测定。
OBJECTIVE To establish an HPLC method for determination of dissolution of isoniazid tablets and evaluation of dissolution curve. Methods The dissolution test was carried out by paddle method at the speed of 50 r / min. The dissolution rate was determined by HPLC with pH1.2 HCl buffer, pH4.5 acetate buffer, pH6.8 phosphate buffer solution and water 900 mL. Dissolution. The results showed that isoniazid had good linearity (r = 0.999 3) at 0.198 1 ~ 0.990 4 μg and the average recovery was 100.2%. The precision, repeatability and specificity were all good. Among the 16 companies tested, four companies had different dissolution profiles in the water from the reference drug Sandoz’s Isoniazid tablets. Conclusion The method of HPLC determination is simple and convenient, and the accuracy and specificity of the determination of isoniazid dissolution are improved. The dissolution method has strong differentiation ability. The method of dissolution determination can be used to determine the dissolution curve of isoniazid tablets.