High Performance Liquid Chromatographic Determination of Pirenzepine Dihydrochloride in Its Pharmaceutical Formulation

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Abstract
A high-performance liquid chromatographic procedure for the determination of pirenzepine dihydrochloride as a bulk material and in its tablet dosage form (Gastrozepin) is presented. Normal phase liquid chromatography has been performed on a Micropack 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 .mu.g/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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