Friday , 15 December 2017

RP-HPLC Method Development and Validation for Simultaneous Estimation of Bupropion and Naltrexone in Bulk and Pharmaceutical Dosage Forms

Sanju Srinivas1, V. Nirmala2
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana
2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana

ABSTRACT
Thus the proposed stability indicating RP-HPLC technique for the synchronic determination of Naltraxone and Bupropione in bulk and pharmaceutical dosage form was accurate, precise, linear, reliable, simple, economic and robust. The method can be used for routine analysis of marketed product of Naltraxone and Bupropione in combined tablet formulation. Water 2695 series with PDA Detector and C18 (Hypersil BDS, 250X4.6mm, 5µ), injection of 10µl was injected and eluted with the mobile phase [Potassium dihydrogen phosphate buffer (pH 4.0 was adjusted with OPA): Acetonitrile) (45:55 v/v)] which was pumped at flow rate of 1.0ml at 230nm. The peak of Naltraxone and Bupropione were found well separated at 2.4676min and 3.805min respectively. The developed method was validated for various parameters as per ICH Guidelines like Among the analytical techniques available in estimation and quantification RP- HPLC method is an emerging technique reliable in vast areas of research that incited the author to undertake method development and validation as per ICH guidelines for the same.Stability indicates for new RP-HPLC technique for synchronic estimation of Naltraxone and Bupropione in bulk and pharmaceutical dosage forms. RP-HPLC method was developed with Water2695 series with PDA detector and C18 (Hypersil BDS, 250X4.6mm, 5µ) column, injection of 10 µl was injected and eluted with the mobile phase of [Potassium di hydrogen phosphate buffer (pH 4.0 was adjusted with Ortho phosphoric acid): Acetonitrile) (45: 55v/v)] which was pumped at flow rate of 1.0ml at 230nm.
Keywords: Bupropion, naltraxone, RP-HPLC, validation, Methanol.

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