Stability Indicating Assay Method for the Determination of Medroxy Progestrone Aceate in Bulk Drug and Formulation by HPTLC

Order of Publishing in Issue: 
7
Volume :11
Issue :3
July, 2017 - September, 2017
Page No: 
286-293
Authors: 
Girish Pai Kulyadi[2], Vasanthraju[1], Prashanth Musmade[1] and Muddukrishna Badamane Sathyanarayana[1]*
Address: 
[1]Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka-576104.
Address: 
[2]Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka-576104.

A sensitive, accurate, precise and stability indicating high-performance thin layer chromatographic assay method for analysis of Medroxyprogestrone acetate (MPA) in both bulk drug and formulation was developed and validated. The method employed HTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of Toluene: ethyl acetate: ammonia solution (80:20:0.1 %v/ v). This system was found to give compact spots for MPA (Rf value 0.32±0.02). MPA was subjected to acid, alkali and neutral hydrolysis, oxidation, sunlight and dry heat treatment. The degraded products were well separated from the pure drug with notably different Rf values. CAMAG HPTLC instrument was used for chromatographic separations. Densitometric analysis of MPA was carried out in the absorbance mode at 240 nm. The linear regression data for the calibration plots showed good linear relationship with correlation coefficient 0.9998 ±/0.001 in the concentration range of 50.0-1800.0ng spot-1. The value of slope and intercept were 11.68 and 73.414 respectively. The method was validated for precision, accuracy, robustness, and recovery. The limits of detection and quantitation were 16.5 and 50.0 ng spot-1 respectively.

Keywords: 
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