盐酸纳曲酮质量控制方法的研究

Comparative study of quality control methods for detecting naltrexone hydrochloride

目的：研究盐酸纳曲酮药物质量控制方法，以监测药物纯度。方法：建立了杂质检查的薄层色谱法和高效液相色谱法。结果：两种方法的最小检测限分别为１％和０．２％。对本所合成的４批样品和进口样品（Ｓｉｇｍａ公司）检测均未检出杂质，而粗品检测则均检出明显杂质，两种方法结果相符。结论：上述两种方法均可用于杂质检查，并获得满意结果，薄层色谱法简便易行。

Objective: To studiy the drug quality control methods for analyzing naltrexone hydrochloride in order to examine the drug purity . Methods: The methods of thin layer chromatography (TLC) and high pressure liquid chromatography (HPLC) were developed to detect the drug impurity. Results: The limits of quantitation observed with these two methods were 1% and 0.2% respectively. Four batches of naltrexone hydrochloride synthesized by this institute and one batch by Sigma Co. were analysed and no impurity was found in samples examined, but obvious impurities were found in crude product samples. The results obtained by two methods were similar. Conclusion: Both of the above mentioned methods used for impurity examination could give satisfactory results, the TLC method is simple and practical and HPLC method has a higher sensitivity than TLC.