Validated Method Development for Estimation of Naproxen sodium as Bulk Drug and in Tablet Dosage Form by HPTLC

Abstract

Naproxen sodium is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties.
The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk
and in tablet dosage form. The chromatographic development was carried out on precoated silica gel
60 F254 aluminium plates using mixture of toluene : ethyl acetate: acetic acid (7.5: 1.5: 1 v/v/v) as
mobile phase and densitometric evaluation of band was carried out at 230 nm using Camag TLC
Scanner-3 with win CAT 1.4.2 version software. The Rf value of drug was found to be 0.63 ± 0.013.
The accuracy and reliability of the proposed method was ascertained by evaluating various validation
parameters like linearity (100-500 ng band-1
), precision (intra-day RSD 0.56-0.87 %, inter-day RSD
0.49-1.39 %), accuracy (99.313 ± 0.467) and specificity according to ICH guidelines. The method was
also evaluated by the assay of commercially available tablets. The % assay (Mean ± S.D., n = 6) was
found to be 99.34 % ± 0.146. The proposed method can analyse ten or more formulation units
simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine
analysis of naproxen sodium as bulk drug and in tablet formulation.