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Analytical RP-HPLC Method for Development And Validation Of Pregabalin In Bulk And The Determination Of Pregabalin In Capsule Dosage Form

JAMPALA BALAJI, BANDI RAMACHANDRA, N.V.S.NAIDU

This work is concerned with application of simple, accurate, precise and selective reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of pregabalin in bulk and determination of pregabalin capsule dosage form. Chromatographic separation was achieved gradiently using waters alliance 2695 separation module, C18 column ( 250 x 4.6 mm, 3.5 μm)at temperature 25o C . Flow rate selected was 0.8 ml/min using PDA detector at 210 nm. Mobile phase was prepared using A-pump 10 mM NH4OAC in water (pH-6.8) and B-pump acetonitrile and methanol in the ratio of 80:20 which gave better resolution and sensitivity. The developed method was validated with respect to linearity, specificity, precession robustness and accuracy.