Development and validation of HPTLC method for simultaneous quantification of Paracetamol, Phenylephrine hydrochloride, Nimesulide, Cetrizine and Caffeine in bulk and pharmaceutical dosage form

A simple and accurate densitometric method has been optimized, developed and validated for the estimation of drugs in bulk and combined dosage form. The Chromatographic analysis was carried out on Merck aluminum plates precoated with silica gel 60 F254 was stationary phase. The optimized mobile phase was toluene: ethyl acetate: methanol: formic acid (16:2:4:0.8, v/v/v/v). The chamber of 20 cm × 20 cm was used and saturation time was 20 minutes. The retardation factor for Paracetamol, Phenylephrine hydrochloride, Nimesulide, Cetrizine and Caffeine was found to be 0.37, 0.09, 0.70, 0.27 and 0.51, respectively. Chromatographic analysis was carried out at 212 nm. The validation was done as per ICH Q2 (R1) Guideline. Linearity range for Paracetamol, Nimesulide, Cetrizine and Caffeine was found to be 200-1400 ng band-1 and that of Phenylephrine hydrochloride, was found to be 100-1400 ng band-1. The proposed method was found to be significant for estimation of drug in bulk and combined dosage form.

Author(s): Sagar S. Vidhate, Sachin E. Potawale, Saurabh S. Kardile, Arun M. Kashid, Amol S. Bansode, Abhijeet A. Bidkar, Hemant M. Washimkarand Pravin D. Pawar

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