International Research Journal of Pharmacy and Pharmacology

International Research Journal of Pharmacy and Pharmacology Vol. 2(10), pp. 245-253, October 2012         
Copyright © 2012 International Research Journals

 

Full Length Research Paper

Optimization and simultaneous determination of gemifloxacin and Non-steroidal anti-inflammatory drugs in bulk, pharmaceutical formulations and human serum by RP-HPLC and its applications

Sana Shamim1*, Najma Sultana1, M. Saeed Arayne2, Mahwish Akhtar1 and Somia Gul1

1Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi, Karachi-75270, Pakistan

2Department of Chemistry, University of Karachi, Karachi-75270, Pakistan

*Corresponding Author E-mail: ssanashamim@yahoo.com;  Tel: 921-03002695075

Received 30 September, 2012; Accepted October 15, 2012

Abstract

A simple and rapid method using high performance liquid chromatography (HPLC) in isocratic mode has been developed for the simultaneous analysis of gemifloxacin (GFX) and non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen (IBU), meloxicam (MEL), mefenamic acid (MEF), flurbiprofen (FLR) and diclofenac sodium (DIC) in bulk, pharmaceutical formulation and human serum. The analytes were analyzed using a Purospher STAR C18 column (250 x 4.6 mm, 5 μm) and a mobile phase consisting of methanol, water and acetonitrile (90 : 5 : 5, v/v/v, pH 2.8 adjusted by phosphoric acid) at a flow rate of 0.8 mL/min. Effluents from the column were monitored  at 240 nm. The proposed method is specific, accurate (99.7 - 100.60%) and precise with intra- and inter-run variations within the limits of 0.12 - 1.96. Linearity was within the desired range of 0.625 – 100 μg/mL, with a correlation coefficient of 0.9991 - 0.9997.  The detection and quantification limits were 0.043 - 0.015 μg/mL and 0.12 - 0.46 μg/mL, respectively. The results were then correlated using Student’s t-test. The proposed method was then applied to study the effect of simulating body environments with respect to pH on in vitro interactions with NSAIDs to elucidate the mechanisms of these interactions. The method was validated for selectivity, linearity, accuracy and precision and was found to be applicable for the routine analysis of GFX and NSAIDs in bulk, pharmaceutical formulations, human serum alone, or in combination and in vitro interaction studies. 

Keywords: Gemifloxacin, NSAIDs, HPLC, validation, human serum. 

 

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