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Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR PREGABALIN AND CELECOXIB IN BULK AND DOSAGE FORMS

G. Swapna* and Merugu Manasa

ABSTRACT

A simple, accurate, precise and highly selective reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for Pregabalin and Celecoxib. Chromatographic separation was achieved isocratically by using waters allaiance 2695 separation module, Hypersil BDS(150 mm x 4.6 mm, 5) at temperature 30oc. Flow rate selected was 1ml/min. Both changes were identified with 238 nm. Mobile phase employed was potassium di hydrogen orthophosphate buffer of pH 6.5 and acetonitrile in the ratio of (70:30) which resulted best resolution and sensitivity. Developed method was validated in terms of linearity, range(37.5 μg/ml-281.25 μg/ml, for Pregabalin, 100 μg/ml -750 μg/ml Celecoxib), precession (correlation coefficient is less than 0.999), robustness, accuracy (recovery of Pregabalin and Celecoxib were 100.3% and 100.13% respectively). The validation of proposed method was verified by recovery studies and can be applicable in routine pharmaceutical analysis.

Keywords: RP-HPLC, Pregabalin, Celecoxib and potassium di hydrogen orthophosphate buffer.


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