High Performance Liquid Chromatographic Determination of Pirenzepine Dihydrochloride in Its Pharmaceutical Formulation
作者:
MohammadA. Abounassif,
期刊:
Analytical Letters
(Taylor Available online 1985)
卷期:
Volume 18,
issue 17
页码: 2083-2089
ISSN:0003-2719
年代: 1985
DOI:10.1080/00032718508067973
出版商: Taylor & Francis Group
关键词: Pirenzepine dihydrochloride determination;Tablet form;High Performance Liquid Chromatography
数据来源: Taylor
摘要:
A high-performance liquid chromatographic procedure for the determination of pirenzepine dihydrochloride as a bulk material and in its tablet dosage form (GastrozepinR) is presented. Normal phase liquid chromatography has been performed on a Micro-pack Si-10 column using ammonium hydroxide (28–30% NH3) in methanol (0.75: 99.25% v/v) as mobile phase at a flow rate of 2 ml/min. Clobazam has been used as internal standard with retention times of 1.9 and 2.8 minutes for clobazam and pirenzepine dihydrochloride, respectively at 254 nm. Analytical calibration yields a linear relationship between 5 and 25 μg/ml, with correlation coefficient of 0.999. Tablets each labelled to contain 25 mg pirenzepine dihydrochloride give mean percentage found of 99.98 ± 0.4. A plot of logarithm of concentration against time for a solution in 6 N hydrochloric acid gives a straight line with a slope of - 0.197 day−1. The proposed method is, therefore, a stability indicating method.
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