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STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF PREGABALIN USING ICH GUIDELINES. Sarvesh Kumar Mishra, B.M.gurupadhyya and Surajpal Verma

STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF PREGABALIN USING ICH GUIDELINES.

Sarvesh Kumar Mishra, B.M.gurupadhyya and Surajpal Verma


International Journal of Natural Product Science 2012: Spl Issue 1:130.

Abstract(RBIP-130)

Pregabalin(PGB) is an anticonvulsant and analgesic medication that is both structurally and pharmacologically related to gabapentin. Literature survey reveals that there is no stability indicating RP-HPLC methods for the estimation of pregabalin. Hence, there is a need for development and validation of sensitive stability indicating analytical method. Stability indicating RP-HPLC method was developed and validated for the estimation of pregabalin. Chromatographic separations were achieved by using a Phenomenex C 18 column (250 x 4.6 mm i.d., 5 µm particle sizes). Mobile phase consisting of acetonitrile and phosphate buffer pH3.5 (60:40 v/v) gave sharp peaks. Other parameters like injection volume were set 40 μl for a run time of 10 min with flow rate 1.0 ml/min. The column was maintained at ambient temperature and the eluent was detected at 210 nm. Retention time of pregabalin at the above chromatographic condition was found to be 2.5 mins. Pregabalin was subjected to various degradation conditions like acidic, alkaline, thermal, oxidation, photo, UV degradation and neutral conditions for a period of 24 hrs and it was found to degrade to different extent in different conditions. Pregabalin was found to be highly degraded at oxidation and photo degradation and comparatively stable under neutral condition. Thus, a novel stability indication RP-HPLC method was successfully developed and validated for the estimation of pregabalin. The developed method was found to be precise, accurate and sensitive and can be routinely used for the estimation of pregabalin in presence of impurities.
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