STANDADADIZATION AND STABILITY INDICATING STUDIES BY RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CANDESARTAN CILEXETIL & HYDROCHLORTHIAZIDE IN TABLET DOSAGE FORM
AbstractA rapid, selective, precise, accurate, rugged and robust high performance liquid chrmatgraphic (HPLC) method for the simultaneous determination of Candesartan Cilexetil & Hydrochlorthiazide in tablet dosage form .The method was validated according to ICH and FDA guidelines. The chromatography is performed on a Kromasil C8, 150 x 4.6 mm, 5µm, in a gradient mode with a mobile phase of Water, acetonitrile and Trifluracetic acid in different ratios. UV-Visible detector at 285 nm was found to be suitable for detection. Linearity was observed in the range of 70 -130μg/ml with correlation coefficient of 0.9999. Sensitivity, accuracy, range, precision, robustness, ruggedness, stability, specificity, limit of detection, limit of quantification and system suitability parameters were validated for the developed method. The developed method was successfully applied to estimate the amounts in pharmaceutical formulations and for the stability indicating studies.
Article Information
49
5438-5446
702KB
1241
English
IJPSR
G. Mani Kumar* and J.V.L.N. Seshagiri Rao
Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences & Technologies, JNTU Kakinada, Kakinada, Andhra Pradesh, India.
gmk777@gmail.com
25 April, 2014
10 July, 2014
15 August, 2014
http://dx.doi.org/10.13040/IJPSR.0975-8232.5(12).5438-46
01 December 2014