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引用次数: 4
摘要
Antihemoroid®栓剂已由印度尼西亚PT. Kimia Farma商业化生产。为便于质量控制，采用分离密度法分析其有效成分盐酸利多卡因和六氯酚。本研究的目的是获得更有效的LH和HC的分析方法，因此建立了同时测定这两种化合物的高效液相色谱方法。色谱柱为AYMC-Triart C18，梯度流动相为乙腈-磷酸盐缓冲液0.05 M (pH 6.0)。在220 nm处进行定量评价。根据usp41的新方法进行方法验证。结果表明，该方法简便、准确、精密度高、鲁棒性好。该方法可作为制药行业的质量控制工具，用于栓剂中LH和HC的同时测定。
Simultaneous HPLC Determination of Lidocaine Hydrochloride and Hexachlorophene in a Suppository Product
Antihemoroid® suppository has been produced commercially by PT. Kimia Farma, Indonesia. For QC purposes, a separated densitometric method for analysis of its active ingredients, lidocaine hydrochloride and hexachlorophene, was applied. The objective of this study was obtaining more efficient analysis method of LH and HC, therefore an HPLC procedure has been developed for the determination of both compounds simultaneously. AYMC-Triart C18 column was used with a gradient mobile phase consisting of acetonitrile and phosphate buffer 0.05 M (pH 6.0). Quantitative evaluation was performed at 220 nm. Method validation was performed according to the new methods of USP 41. Result showed that the HPLC method was simple, accurate, precise, and robust. The HPLC method can be applied in simultaneous determination of LH and HC in suppositories as a QC tool in the pharmaceutical industries.
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