Research Journal of Pharmacy and Technology

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Stability Indicating UPLC Method for Simultaneous Estimation of Epalrestat and Pregabalin in Tablet Dosage Form


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1 PG Department of Chemistry, JKC College, Guntur, Andhra Pradesh, India
     

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A stability indicating ultra pressure liquid chromatographic method was developed and validated for the simultaneous estimation of Epalrestat and Pregabalin in bulk and tablet dosage form. The study was performed using HSS column (100mm x 2.1 mm, 1.8), with a mobile phase consisting of 0.1% o-phosphoric acid buffer (55% v/v) and acetonitrile (45%v/v) at a flow rate of 0.3ml/min.The detection was carried at 210 nm using PDA detector and the retention times were found to be 1.704 and 1.084 min for Epalrestat and Pregabalin respectively. The method was found to be linear in the concentration range of 37.5–225 μg/ml for Epalrestat and Pregabalin with r2= 0.999.These drugs were subjected to stress conditions such as acidic, basic, peroxide, thermal and photo degradation. The method was validated according to ICH guidelines.

Keywords

Epalrestat, Pregabalin, UPLC, Degradation, ICH.
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  • Stability Indicating UPLC Method for Simultaneous Estimation of Epalrestat and Pregabalin in Tablet Dosage Form

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Authors

T. Sravanthi
PG Department of Chemistry, JKC College, Guntur, Andhra Pradesh, India
N. Madhavi
PG Department of Chemistry, JKC College, Guntur, Andhra Pradesh, India

Abstract


A stability indicating ultra pressure liquid chromatographic method was developed and validated for the simultaneous estimation of Epalrestat and Pregabalin in bulk and tablet dosage form. The study was performed using HSS column (100mm x 2.1 mm, 1.8), with a mobile phase consisting of 0.1% o-phosphoric acid buffer (55% v/v) and acetonitrile (45%v/v) at a flow rate of 0.3ml/min.The detection was carried at 210 nm using PDA detector and the retention times were found to be 1.704 and 1.084 min for Epalrestat and Pregabalin respectively. The method was found to be linear in the concentration range of 37.5–225 μg/ml for Epalrestat and Pregabalin with r2= 0.999.These drugs were subjected to stress conditions such as acidic, basic, peroxide, thermal and photo degradation. The method was validated according to ICH guidelines.

Keywords


Epalrestat, Pregabalin, UPLC, Degradation, ICH.

References