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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR SIMULTANEOUS ESTIMATION OF DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLETS USING RP-UPLC METHOD

Panchal Vipul J*, Dr. Desai Hemant T, Patel Niharika A, Dave Ashwin G,
Panchal Kalpesh B

ABSTRACT

2Rai University, Saroda, Dholka, Ahmedabad, Gujarat, India-382260. ABSTRACT This research manuscript describes simple, sensitive, accurate, precise and repeatable RP- UPLC method for the simultaneous determination of Doxylamine Succinate (DOX) and Pyridoxine Hydrochloride (PYH) Tablets in combine dosage form. The sample was analyzed by reverse phase C18 column (Acquity UPLC BEH 100 × 2.1 mm ID, 1.7 μm) with mobile phase. 0.05 M potassium dihydrogen phosphate Buffer: Acetonitrile (70:30 v/v) was use as mobile phase. 0.3 ml/minute was use as flow rate. Quantification was achieved at 260 nm with PDA detector. The retention time of Pyridoxine Hydrochloride and Doxylamine Succinate was found 0.678 and 1.482 minute respectively. The linearity of Pyridoxine Hydrochloride and Doxylamine Succinate was obtained in the concentration range of 40-280 μg/ml respectively. The developed method was simple, specific, sensitive, rapid, and economic. It can be used for estimation of Doxylamine Succinate (DOX) and Pyridoxine Hydrochloride (PYH) in bulk and their combined dosage form for routine analysis and stability studies.

Keywords: Doxylamine Succinate, Pyridoxine Hydrochloride, Method validation, RPUPLC, Forced degradation.


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