Simultaneous Determination of Chlorpheniramine Maleate, Paracetamol and Phenylephrine Hydrochloride in Tablet Dosage Form by High Performance Liquid Chromatography

A new simple, rapid and sensitive HPLC method has been developed and validated for the simultaneous determination of chlorpheniramine maleate, paracetamol and phenylephrine hydrochloride in pharmaceutical preparation. Separation was achieved on a 250mm x 4.6mm, 5μm particle, C8 column using an isocratic mobile phase consisting of 0.01M phosphate buffer: acetonitrile (70:30), pH of the mobile phase was adjusted at 3 with 50% orthophosphoric acid. The analysis was performed at flow rate of 1mLmin-1. Detection of all compounds was carried by UV absorbance at 230nm and elution of the analytes was achieved in less than 8 minutes. The method was validated as per ICH guidelines. The linearity, accuracy and precision of the method were acceptable to good over the concentration range of 5- 60μg mL-1 for all the three drugs. The lower limit of detection was found to be 0.36, 0.36 and 0.28μg mL-1 for chlorpheniramine maleate, paracetamol and phenylephrine hydrochloride respectively. The developed method is effectively used for the routine analysis of formulations for both quality control and assessment of stability.

Author(s): Sehrawat Renu, Khatak Mamta, Maithani Mukesha, Khatak Sunilb

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