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目的建立高效液相色谱法测定头孢克洛缓释胶囊体外释放度的方法。方法采用Lichroshper-C18色谱柱(250mm×4.6mm,5μm),以磷酸二氢钾溶液(磷酸二氢钾6.8g,加水溶解并稀释至1000ml,用磷酸调节pH值至3.4)-乙腈(92∶8)为流动相;流速为1.0ml/min;检测波长为254nm;柱温为30℃。结果头孢克洛在4-40μg/ml范围内峰面积与浓度呈良好的线性关系(r=0.9999);平均加样回收率为99.5%,相对标准差为0.59%;在30、60min、4h的体外释放度分别为(25.60±1.26)%、(45.79±1.68)%、(98.13±1.77)%;3批样品测定的释放度重现性良好。结论高效液相色谱法测定头孢克洛缓释胶囊体外释放度操作简便,结果准确,药物的体外释放符合Higuchi方程。
Objective To establish a HPLC method for the determination of cefaclor sustained-release capsules in vitro release method. Methods A Lichroshper-C18 column (250 mm × 4.6 mm, 5 μm) was used with potassium dihydrogen phosphate (potassium dihydrogen phosphate 6.8 g, dissolved in water and diluted to 1000 ml, adjusted to pH 3.4 with phosphoric acid) 8) as mobile phase; the flow rate was 1.0ml / min; the detection wavelength was 254nm; the column temperature was 30 ℃. Results The peak area of cefaclor in the range of 4-40μg / ml showed a good linear relationship with the concentration (r = 0.9999), the average recovery was 99.5% and the relative standard deviation was 0.59%. At 30, 60min and 4h The in vitro release rates were (25.60 ± 1.26)%, (45.79 ± 1.68)% and (98.13 ± 1.77)%, respectively. The release of three batches of samples was reproducible. Conclusion HPLC determination of cefaclor sustained-release capsules in vitro release is simple and accurate, the results in vitro release in line with Higuchi equation.