Abstract

METHOD DEVELOPMENT AND VALIDATION OF REVERSE PHASE HPLC FOR PREGABALIN IN PHARMACEUTICAL DOSAGE BY REVERSE PHASE HPLC

Dr. Battula Sreenivasa Rao* and K. Nagendra Rao

ABSTRACT

A rapid, specific and accurate isocratic HPLC method was developed and validated for the assay of Pregabalin in pharmaceutical dosage forms. The assay involved an isocratic – elution of Pregabalin in Grace C18 column using mobile phase composition consists of (50:50 v/v) of Methanol & 10mM Ammonium Acetate (pH adjusted to 3.0 with acetic acid). The wavelength of detection is 210nm.The method showed good linearity in the range of 90 – 104 mg/mL. The runtime of the method is 5 mins. The proposed method can be used for routine quality control samples in industry in bulk and in finished dosage forms. In present study, a rapid specific precise and validated HPLC method for the quantitative estimation of Pregabalin in pharmaceutical dosage forms has been reported. The developed method can be applied to directly and easily to the analysis of the pharmaceutical tablet preparations. The percentage recoveries were near 100% for given methods. The method was completely validated and proven to be rugged. The excipients did not interfere in the analysis. The results showed that this method can be used for rapid determination of Pregabalin in pharmaceutical tablet with precision, accuracy and specificity.

Keywords: Pregabalin, Assay, reverse phase, HPLC.