Wednesday , 17 August 2022

Development, Validation & Degradation Studies of RP-HPLC Method for the Determination of Pregabalin in Oral Suspension Powder

Eswara Rao Bammidi*1, Vaikuntarao Lakinani1, Subrahmanyam Lanka1, Pavitra Paila1, Mallikarjun Rao Duvvada2
1Departmernt of Chemistry, GITAM Institute of Science, GITAM University, Visakhapatnam, A.P., India
2Departmernt of Environmental Sciences, GITAM Institute of Science, GITAM University, A.P., India

A B S T R A C T
A simple, rapid, selective, precise and accurate reverse phase HPLC method has been developed for the estimation of Pregabalin in oral dosage forms. The mobile phase consisted of 50:50 (v/v) of Acetonitrile & Buffer. The flow rate is 1 ml/min. Chromatographic determination of Pregabalin was performed on Phenomenex C18 column (150 X 4.6 mm Id, ODS 5μm). The wavelength of detection is 262 nm. The injection volume is 10μL. The retention time of Pregabalin is 2.501 ± 0.09 minutes. The developed method was validated in terms of accuracy, precision, linearity, and limit of detection, limit of quantitation, solution stability, ruggedness, and robustness. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress conditions on Pregabalin was studied. Results indicated that pregabalin is stable under the experimental conditions with a high baseline noise observed in alkaline medium. The proposed method has been successfully used for the routine analysis of pregabalin in oral suspension powder.
Keywords: Pregabalin, GABA, Anticonvulsant, HPLC

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