DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF TROXIPIDE
AbstractA simple sensitive, accurate, precise and stability indicating high performance thin layer chromatographic method has been developed and validated for the estimation of troxipide in bulk drug and formulation. The method was developed using silica Gel 60 F254TLC plates, with hexane: ethyl acetate: methanol: water: ammonia 1: 5: 5: 1.5:0.2 (v/v) as mobile phase. The densitometric scanning was performed at λ = 263 nm. The method was validated for linearity, accuracy, precision, specificity and robustness according to ICH guidelines. The calibration plots were linear in the range 200-700 ng/band with r2= 0.998. The LOD and LOQ were found to be 20.39 and 61.81 ng/spot, respectively. Troxipide was subjected to acidic, alkaline hydrolysis, oxidation, photo degradation and thermal degradation. The drug undergoes degradation in acidic as well as alkaline hydrolysis and thermal degradation; however it was found to be relatively stable for photolytic and oxidative degradation conditions. As the drug peak and the degradation product peaks were well separated from each other; this method can be employed as stability indicating method for the determination of troxipide and its degradation products from API and formulation
Article Information
35
300-306
444
1554
English
IJPSR
Arti V. Gajbhar and B. S. Kuchekar *
Department of pharmaceutical Chemistry, MAEER’s Maharashtra Institute of Pharmacy, S. No. 124, MIT campus, Ex- Serviceman Colony, Paud Road, Kothrud, Pune, Maharashtra, India
arti.gajbhar@mippune.edu.in
23 July, 2015
28 August, 2015
06 November, 2015
10.13040/IJPSR.0975-8232.7(1).300-06
01 January, 2016
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