ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF RUPATADINE FUMARATE AND MONTELUKAST SODIUM BY RP-HPLC
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 7
Abstract
ABSTRACT A sensitive, selective and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Rupatidine fumarate and Montelukast sodium in tablet dosage form. The method employed like C18 column, Symmetry C18 (4.6 x 250mm, 5m, Make: Waters) as the stationary phase while Phosphate buffer (pH 3.6), Methanol, Acetonitrile in proportion 30:65:5 v/v respectively. was used as mobile phase. The Retention time of Rupatadine fumarate and Montelukast sodium were observed to be 2.395 and 3.339 minutes, respectively. The flow rate was found to be 1ml/min and effluents were monitored at 230 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for both Rupatadine fumarate and Montelukast sodium and over a concentration range of 10- 50 μg/ml. with correlation co-efficient of 0.9989 for Rupatadine fumarate and 0.9999 for Montelukast sodium The LOQ was found to be 4.52 and 3.67μg/ml respectively for Rupatadine fumarate and Montelukast sodium. The method was validated as per ICH guideline and it was found to be accurate, precise and robust. Marketed formulation was analyzed successfully. Keywords: Rupatadine fumarate, Montelukast sodium, HPLC, Validation etc.
Authors and Affiliations
Nidhi NK*, Neelam I, Ajitha A, Uma Maheswara RaoV
Keywords
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