Comparative determination of chlorpromazine hydrochloride content in multi-sourced chlorpromazine tablets in Nigeria

H. Okeri, P. Alonge, E. Etareri
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引用次数: 1

Abstract

Purpose: Although different brands or unbranded chlorpromazine tablets from multiple sources are available in Nigeria today, they must all contain the same active principle and satisfy the standards of quality, efficacy and safety. This study is designed to check for possible faking and adulteration of chlorpromazine tablets and also establish the possibility of inter-brand substitution based on drug content (chemical equivalence). Method: The determination of the chlorpromazine hydrochloride content was carried using non-aqueous titrimetric and spectrophotometric methods. Glacial acetic acid and acetone were used as the non-aqueous solvent and equivalence points were determined using visual indicators and potentiometer. Results: The results obtained showed that all the brands analyzed met the specification of the British Pharmacopoeia and so contain acceptable amounts of chlorpromazine drug content thus enabling possible brand substitution. Statistical comparison showed no significant difference between the results obtained by determining end-point using visual indicators and the potentiometer. Conclusion: The use of the visual indicator method is recommended for fast and accurate routine laboratory analytical work especially in developing nations. Keywords: Chlorpromazine, non-aqueous titration, spectrophotometric determination, potentiometry
尼日利亚多源氯丙嗪片中盐酸氯丙嗪含量的比较测定
目的:虽然目前在尼日利亚有来自多个来源的不同品牌或无品牌氯丙嗪片,但它们必须含有相同的活性成分,并满足质量、功效和安全标准。本研究旨在检查氯丙嗪片是否存在伪造和掺假的可能,并根据药物含量(化学等效)确定品牌间替代的可能性。方法:采用非水滴定法和分光光度法测定盐酸氯丙嗪的含量。以冰醋酸和丙酮为非水溶剂,用目测指示剂和电位器测定等当点。结果:所分析的各牌号均符合英国药典的规定,氯丙嗪的药物含量可接受,有替代牌号的可能。统计比较表明,用目测仪测定终点与电位器测定终点的结果无显著差异。结论:尤其在发展中国家,推荐使用目视指示法进行快速、准确的常规实验室分析工作。关键词:氯丙嗪,非水滴定,分光光度法,电位法
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