P Venkata Suresh, GV Srujana, G Lavanya, KML Manoja, M Hadassah, B Srilekha, S Vasudha Lakshmi and N Rama Rao
P. VenkataSuresh*, G.V. Srujana, G. Lavanya, K.M.L. Manoja, M. Hadassah, B. Srilekha, S. Vasudha Lakshmi and N.Rama rao
Dept. of Pharmaceutical Analysis, Chalapathi Institute of Pharmaceutical Sciences, Lam, Guntur-34, India.
Volume - 4,
Issue - 1,
Year - 2011
A simple, sensitive, rapid, robust and reproducible method for the determination of Raloxifene hydrochloride in bulk and pharmaceutical formulation (Tablets) was developed using reverse phase high performance liquid chromatographic method (RP-HPLC). The RP-HPLC analysis was performed isocratically on Equisil-ODS (octadecylsilane; C18), 5µ, 4.6 x 250 mm analytical column using a mobile phase consisting of 0.02M potassium dihydrogen ortho Phosphate buffer (pH adjusted to 3.00 ± 0.01 with ortho phosphoric acid after addition of 0.1% triethyl amine), Methanol, Acetonitrile in the Ratio of 40:30:30 (v/v/v) with a flow rate of 1mL/min. The analyte was monitored with UV detector at 282 nm. The developed method Raloxifenehydrochloride elutes at a retention time of 2.70 min. The proposed method is having linearity in the concentration range from10 to70 µg/mL of Raloxifenehydrochloride. The present method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery), ruggedness, robustness, stability, forced degradation studies (specificity).The proposed method can be readily utilized for bulk drug and pharmaceutical formulations.
Cite this article:
P Venkata Suresh, GV Srujana, G Lavanya, KML Manoja, M Hadassah, B Srilekha, S Vasudha Lakshmi and N Rama Rao. Development and Validation of Isocratic RP-HPLC Method for Raloxifene Hydrochloride in Bulk and Pharmaceutical Formulation. Research J. Pharm. and Tech. 4 (1): January 2011; Page 146-149.