| HPLC法测定复方苯海拉明乳膏中盐酸苯海拉明的含量 |
| 投稿时间：2021-02-22 修订日期：2022-01-10 点此下载全文 |
| 引用本文：陆松伟,骆锦前,虞慧华,陈方剑.HPLC法测定复方苯海拉明乳膏中盐酸苯海拉明的含量[J].药学实践杂志,2022,40(3):274~276 |
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| 中文摘要:目的 建立HPLC法测定复方苯海拉明乳膏中盐酸苯海拉明的含量。方法 色谱柱为ACE5C18S/N-A66766柱（150 mm×4.6 mm，5 μm）；流动相为甲醇-水-三乙胺（70:30:0.67，用磷酸调pH为6.5）；检测波长设定230 nm；流速设定1.0 ml/min；乳膏经过提取净化后进样20 μl在室温下分析。结果 盐酸苯海拉明在39.52～197.6 μg/ml范围内线性关系良好（r=0.999 7），平均回收率为100.5%（RSD=1.25%，n=9），重复性结果显示RSD为0.78%（n=6），所测得盐酸苯海拉明乳膏含量结果为标示量的101.3%、99.83%、99.62%。结论 本方法准确、灵敏、专属性强、重现性好，对复方苯海拉明乳膏质量控制标准的提高具有参考意义。 |
| 中文关键词:复方苯海拉明乳膏 盐酸苯海拉明 高效液相色谱法 |
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| Diphenhydramine hydrochloride asaay in compound diphenhydramine cream by HPLC |
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| Abstract:Objective To establish the HPLC method of assay for diphenhydramine hydrochloride in compound diphenhydramine cream. Method HPLC analysis was carried on ACE5C18S/N-A66766 column (150 mm×4.6 mm, 5 μm) with the mobile phase of methanol-water-triethylamine (70:30:0.67, adjusting pH to 6.50 with phosphoric acid) at room temperature. The detection wavelength was set at 230 nm and the flow rate was 1.0 ml/min. The analyte was extracted from the cream and 20 μl of sample was injected. Results The calibration curve of diphenhydramine hydrochloride was linear in the range of 39.52-197.6 μg/ml (r=0.999 7). The average recovery of diphenhydramine hydrochloride was 100.5% (RSD=1.25%, n=9). The repeatability of the method was expressed using RSD with 0.78% (n=6). The results of assay were 101.3%, 99.83% and 99.62%. Conclusion The method is accurate, sensitive, selective and repeatable, which can be applied for improving the quality standard of compound diphenhydramine cream. |
| keywords:compound diphenhydramine cream diphenhydramine hydrochloride HPLC |
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