Abstract

Stability-Indicating LC Method for Analysis of Zaltoprofen in Bulk Drug Formulations

Author(s): Kiran B. Aher1*,Girija B. Bhavar1, Sanjay R. Choudhari1, Hemant P. Joshi2

A simple, rapid, and precise LC method has been developed for quantitative analysis of Zaltoprofen (ZLT) in pharmaceutical Bulk dosage forms. Chromatographic separation of ZLT and its degradation products was achieved on a C18 analytical column with 0.01 M Potassium dihydrogen phosphate – acetonitrile, 80:20 (v/v), as mobile phase. The flow rate was 1.0 mL min−1, the column temperature 25 °C, and detection was by absorption at 233 nm using a photodiode-array detector and UV detector. The tailing factor for ZLT was 1.07. ZLT was exposed to thermal, photolytic, hydrolytic, oxidative stress conditions as per ICH guidelines and were analysed by use of the proposed method. Peak homogeneity data for ZLT in the chromatograms from the stressed samples, obtained by use of the photodiode-array detector, demonstrated the specificity of the method for analysis of ZLT in the presence of the degradation products. The linearity of the method was excellent over the range 10–140 μg mL−1 ZLT. The correlation coefficient was 0.9999. Relative standard deviations of peak areas from six measurements were always less than 2%. Each analysis required no longer than 10 min. The proposed method was found to be suitable, stability indicating and accurate for quantitative analysis of ZLT in bulk drug samples and also study its stability.

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