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高效液相色谱法测定化痰平喘片中盐酸异丙嗪的含量及含量均匀度
Assay and content uniformity of promethazine hydrochloride in Huatanpingchuan tablets by HPLC
【摘要】 目的建立化痰平喘片中盐酸异丙嗪的含量及含量均匀度的HPLC测定方法。方法色谱柱为DiamonsilC18柱,流动相为乙腈-水-三乙胺(40∶60∶0.3)(用磷酸调pH至4.0),流速为1.0 mL.min-1,检测波长为249 nm,柱温:30℃,进样量:10μL。结果盐酸异丙嗪在0.61~2.44μg线性关系良好(r=0.9999,n=5),平均加样回收率为97.6%(RSD=0.9%)。结论该方法简便、准确,可用于该制剂的质量控制。
【Abstract】 Objective To establish an HPLC method for the content and uniformity determination of promethazine hydrochloride in Huatanpingchuan tablets.MethodsDiamonsil C18 column was used.The mobile phase consisted of acetonitrile-water-trithylamine(40∶60∶0.3)(adjusted pH to 4.0 by phosphoric acid),the flow rate was 1.0 mL·min-1,and the detection wavelength was 249 nm.The column temperature was 30 ℃ and the injection volume was 10 μL.ResultsThe calibration curve was linear at 0.61~2.44 μg for berberine hydrochloride,and the average recovery was 97.6%(RSD=0.9%).ConclusionThe method is simple and accurate.It is suitable for the quality control of Huatanpingchuan tablets.
【Key words】 HPLC; Huatanpingchuan tablets; promethazine hydrochloride; content; content uniformity;
- 【文献出处】 中南药学 ,Central South Pharmacy , 编辑部邮箱 ,2009年07期
- 【分类号】R927
- 【下载频次】77