Validation of an RP-HPLC Method to Determine Rupatadine as a Fumarate in Pharmaceutical Dosage Form

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Rupatadine (RUP) is a second generation antihistamine drug and an agonist of platelets activating factor. Literature does not report any specific method for the determination of RUP. Therefore, a Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed in this research for the quantitative determination of RUP in pharmaceutical dosage form. For this purpose, a mixture of monosodium phosphate buffer and acetonitrile 80:20 v/v was used as mobile phase, flowing at a rate of 1.0 ml/min. A well-characterized reference material of RUP with a potency of 99.68% (as is basis) was used throughout the study. RUP for system suitability chemical related substances (CRS) (containing impurities A and B) was also used in this study for the identification of fumaric acid, impurity A, impurity B, and RUP in the pharmaceutical dosage form. Method validation was performed by the preliminary analysis of the standard sample and by performing recovery studies. The method was found to be linear with regression line y = 95464x -6164, having correlation 1.0000, in the range of 17.04-85.20 µg/ml. Moreover, percentage recovery of RUP was found to be in the range of 99.08 to 100.25. The limit of detection (LOD) was found to be 0.63 µg/ml and the limit of quantification (LOQ) was found to be 1.91µg/ml. It can be inferred from the obtained results that the developed method is simple, linear, precise, accurate, and robust. Therefore, it can be employed for the quantitative determination of RUP in the pharmaceutical dosage form.