A.K.R.G College of Pharmacy

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NAPROXEN IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP-HPLC

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ABOUT AUTHORS
S. Ashutosh Kumar*, Manidipa Debnath,Vaddi Pavan Krishna Kumar

Department of Pharmaceutical Analysis and Quality Assurance,
A.K.R.G College of Pharmacy,
Nallajerla, West Godavari, A.P
* ashu.mpharm2007@gmail.com

ABSTRACT
Purpose:
A simple, precise, accurate, rapid and economical reverse phase high-pressure liquid chromatographic method has been developed as per ICH norms for the estimation of Naproxen from pharmaceutical formulation.
Methods: The method was carried out on a Kromosil-C18 ODS column (150 mm X 4.6 mm; 5 µ) with a mobile phase consists of ammonium acetate buffer (adjusted to pH 4.0 with 1 % Triethyl amine): methanol (40:60 v/v) and filtered through a 0.45 µ cellulose nitrate filters. The flow rate was maintained in isocratic mode at 1.0 mL/min. The detection was carried out at 210 nm. The run time was 7.0 min.
Results: The retention time was 3.063 min for Naproxen. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability.
Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of Naproxen in bulk as well as in tablet dosage forms.