Journal :   Asian Journal of Research in Chemistry

Volume No. :   6

Issue No. :  6

Year :  2013

Pages :   546-551

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Development and Validation of Stability Indicating HPTLC Method for Estimation of Ursolic Acid

Address:   Mitali A. Patel and Niraj Vyas*
Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa - 388421. Ta. Petlad, Dist. Anand, Gujarat, India.
*Corresponding Author

A stability indicating high performance thin layer chromatographic (HPTLC) method was developed and validated for estimation of ursolic acid. Study was performed on pre-coated silica gel TLC plates using toluene: ethyl acetate: formic acid (7:3:0.1, v/v/v) as the mobile phase. After development, plates were derivatized with Anisaldehyde-Sulphuric acid reagent. Detection and quantification were performed by densitometric scanning at 530 nm. Method was validated according to ICH Q2(R1)guideline. The linear regression analysis for the calibration plot showed good linear relationship over the concentration range of 200–600 ng/spot. The correlation coefficient of calibration curve was found to be 0.9986. The intra and inter day precision was found to be less than 2%. Ursolic acid was also subjected to acid, base, oxidation, heat, humidity and photo-degradation studies. The degradation products obtained were well resolved from the pure drug with significantly different Rf values. As the method could effectively separate the drugs from its degradation products, it can be used for stability-indicating analysis.
Ursolic acid, Stability indicating method, High Performance Thin Layer Chromatography (HPTLC), method validation.
Mitali A. Patel, Niraj Vyas. Development and Validation of Stability Indicating HPTLC Method for Estimation of Ursolic Acid. Asian J. Research Chem. 6(6): June 2013; Page 546-551.
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