A simple, specific, accurate and precise RP-HPLC method has been developed and Validated for the Simultaneous Estimation of Paracetamol, Cetirizine hydrochloride, Chlorpheniramine maleate and Dextromethorphan hydrobromide in their combined dosage form (tablet). The separation of four components was carried out using Hypersil C18 (250 × 4.6 mm, 5 µm or equivalent) column by isocratic elution with a flow rate of 1.2ml/min. The mobile phase composition was 0.01 M Sodium perchlorate buffer solution adjusted to a pH of 3 with orthophosphoricacid: acetonitrile (60:40 v/v) and detection was carried out at 210 nm. The retention time of Paracetamol, Cetirizine hydrochloride, Chlorpheniramine maleate and Dextromethorphan hydrobromide were 2.943 min, 9.950 min, 2.447 min and 6.577 min respectively. The method has been validated in terms of linearity, specificity, accuracy, precision, limit of detection, limit of quantitation, robustness as per ICH guidelines. The method has been found to be linear in the range of 325-975 µg/ml (R2=0.9987) for Paracetamol, 5-15 µg/ml (R2=0.999) for Cetirizine hydrochloride, 2-6 µg/ml (R2=0.999) for Chlorpheniramine maleate and 15-45 µg/ml (R2=0.9984) for Dextromethorphan hydrobromide respectively. The limit of detection and limit of quantitation were 0.391 and 0.9671 for Paracetamol, 0.0092 and 0.0279 for Cetirizine hydrochloride, 0.0203 and 0.0617 for Chlorpheniramine maleate and 0.0114 and 0.0346 for Dextromethorphan hydrbromide respectively. The recoveries of Paracetamol, Cetirizine hydrochloride, Chlorpheniramine maleate and dextromethorphan hydrobromide were 99.85%, 99.91%, 99.36% and 99.82% respectively and their relative standard deviations were less than 2%. Hence, the method could be successfully applied for routine analysis of Paracetamol, Cetirizine hydrochloride, Chlorpheniramine maleate and Dextromethorphan hydrobromide in their combined tablet dosage form.
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