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*
Department of Chemistry, Sri Venkateswara University, Tirupathi, India
|Corresponding Author: N.V.S.NAIDU,|
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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.