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目的:统一《中国药典》中马来酸氯苯那敏片与注射液含量测定的方法。方法:色谱条件:色谱柱Inertsil C8柱(150mm×4.6 mm,5μm);流动相:以磷酸盐缓冲液(取磷酸二氢铵11.5 g,加水适量使溶解,加磷酸1 ml,用水稀释至1 000 ml)-乙腈(70∶30)为流动相;流速为1.0 ml·min-1;柱温:室温;进样量:10μl;检测波长262 nm。结果:氯苯那敏在0.017 8~0.445 0 mg·ml-1范围内呈良好线性关系(r=0.999 9)。平均回收率:片剂为100.2%(RSD=0.4%,n=9),注射液为100.3%(RSD=0.9%,n=9)。结论:此法操作简单,重复性好,结果准确,为统一马来酸氯苯那敏片、注射液及滴丸的含量测定提供参考。
Objective: To unify the determination of chlorphenamine maleate tablets and injection in “Chinese Pharmacopoeia”. Method: Chromatographic conditions: Column Inertsil C8 (150 mm × 4.6 mm, 5 μm); mobile phase: phosphate buffer (take ammonium dihydrogen phosphate 11.5 g, add water to dissolve, add phosphoric acid 1 ml, diluted with water 000 ml) -acetonitrile (70:30) as the mobile phase at a flow rate of 1.0 ml · min-1. The column temperature was at room temperature. The injection volume was 10 μl. The detection wavelength was 262 nm. Results: Chlorphenamine showed a good linearity (r = 0.999 9) in the range of 0.017 8-0.445 0 mg · ml-1. The average recovery was 100.2% for tablets (RSD = 0.4%, n = 9) and 100.3% for injection (RSD = 0.9%, n = 9). Conclusion: This method is simple, reproducible and accurate. It provides a reference for the determination of chlorphenamine maleate tablets, injection and dropping pills.