A validated RP-HPLC method for the simultaneous estimation of paracetamol and naproxen in bulk and tablet dosage forms
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2013, Vol 2, Issue 4
Abstract
A simple, sensitive, accurate, precise, reproducible, specific and cost-effective RP-HPLC method was developed and validated for the simultaneous estimation of Paracetamol (PCM) and Naproxen sodium (NPX) in the bulk and pharmaceutical dosage forms. Chromatography was carried on a Nucleosil C8 (250 X 4.6 mm, 5μm) column with mobile phase comprising of phosphate buffer pH-6.5 adjusted with 1N potassium hydroxide and acetonitrile in the ratio of 70:30 v/v. The flow rate was adjusted to 1.0 ml/min with UV detection was carried out at 240 nm, and column temperature of 30±0.50 C was maintained throughout the study. The retention times for PCM and NPX were found to be 3.54 min and 4.59 min respectively. Linearity values were obtained in the range of 2.5-15 µg/ml for PCM and 2-12 µg/ml for NPX with correlation coefficient (r2) of 0.999 for both drugs. The method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantification. So the proposed method was found to be suitable for the routine quality control analysis of these drugs in raw materials and also in pharmaceutical dosage forms.
Authors and Affiliations
Krishanu Pal
Keywords
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