摘要
目的建立高效液相色谱法(HPLC)同时测定曲安奈德新霉素贴膏中麝香草酚和醋酸曲安奈德的含量。方法采用C18色谱柱(150 mm×4.6 mm,5μm),以甲醇-水(57:43)为流动相,柱温30℃,流速1.0 ml/min,检测波长240 nm。结果麝香草酚浓度与峰面积在0.0454~0.0907 mg/ml范围内呈良好的线性关系(r=0.9995),平均回收率为101.11%,RSD=0.42%(n=6);醋酸曲安奈德浓度与峰面积在0.0050~0.0101 mg/ml范围内呈良好的线性关系(r=0.9995),平均回收率100.08%,RSD=0.47%(n=6)。结论本文方法简便,快速,准确,重现性好。可用于该制剂质量评价和生产工艺监控的有效方法。
Objective To establish an HPLC method for the determination of triamcinolone acetonide acetate and thymol in Triamcinolone Acetonide and Neomycin Paste at the same time. Methods A C18 column(150 mm×4.6 mm, 5 μm) was used with methanol-water(57:43) as mobile phase at 30 ℃, the flow rate was 1.0 ml/min, the UV detection wavelength was 240 nm. Results The linear range was 0.0454-0.0907 mg/ml(r=0.9995) for thymol, the average recovery was 101.11 %, with RSD of 0.42 %(n=6). The linear range was 0.0050-0.0101 mg/ml(r=0.9995) for triamcinolone acetonide acetate. The average recovery was 100.08 %, with RSD of 0.47 %(n=6). Conclusion The method is simple, rapid, accurate and reproducible, and can be used for the control of the product quality and preparation process.
引文
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