卡马西平片溶出度方法的改进研究及溶出行为的评价

发布时间：2019-01-04 14:44

【摘要】：目的:改进卡马西平片溶出度检测方法并对不同样品进行溶出曲线评价。方法:采用HPLC法,使用Kromasil 100-5C18Dimensions(250 mm×4.6 mm,5μm)色谱柱,以0.051 8 mol·L-1醋酸铵(冰醋酸调节p H至4.0)-甲醇(65∶35)为流动相,流速1.0 m L·min-1,检测波长为285 nm;溶出度试验采用桨法,以含0.2%十二烷基硫酸钠的p H 6.8磷酸缓冲液为溶出介质,转速为75 r·min-1。结果:在本文色谱条件下,卡马西平质量浓度在5.540~221.6"g·m L-1(r=1.000)检测范围内线性关系良好;低、中、高3种浓度的平均回收率分别为98.7%、100.0%和99.1%,RSD分别为0.78%、0.20%和0.94%,该色谱方法较好地对卡马西平溶出量进行了测定;溶出度方法较好地反映了不同厂家不同批次间卡马西平片溶出行为的差异。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。
[Abstract]:Objective: to improve the dissolution detection method of carbamazepine tablets and evaluate the dissolution curves of different samples. Methods: Kromasil 100-5C18Dimensions (250 mm 脳 4. 6 mm,5 渭 m) column was used with 0.051 8 mol L-1 ammonium acetate (acetic acid to adjust pH to 4.0) -methanol (65:35) as mobile phase. Flow rate 1.0 mL min-1, detection wavelength 285 nm; Dissolution test was carried out by paddle method with pH 6.8 phosphate buffer containing 0.2% sodium dodecyl sulfate as dissolution medium at a rotational speed of 75 r min-1.. Results: under the chromatographic conditions, the linear range of carbamazepine was within the range of 5.540,221.6 "g mL ~ (-1) (rn ~ (1.000). The average recoveries of low, medium and high concentrations of carbamazepine were 98.7100.0% and 99.1%, respectively. The RSD was 0.78% and 0.94%, respectively. The dissolution of carbamazepine was determined by this chromatographic method. The dissolution method reflected the different dissolution behavior of carbamazepine tablets in different batches. Conclusion: the established chromatographic conditions are simple and convenient, and improve the specificity and accuracy of dissolution detection. The improved dissolution method reflects the difference between tablets.
【作者单位】：浙江省食品药品检验研究院;杭州艾品医药科技有限公司;浙江省药品化妆品审评中心;
【分类号】：R927

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