A Novel validated RP-HPLC method for the estimation of “Rupatadine” in its Bulk and Pharmaceutical Dosage forms

CH. Naveen Kumar*, Arvapalli Rajani, Vemula Madhavi Latha, Vijaya Kuchana
Department of Pharmaceutical Analysis and Quality Assurance, Teegala Krishna Reddy College of Pharmacy, Hyderabad, India

Abstract
A Novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the Estimation of “Rupatadine” has been developed. The developed method was found and proved to be a better one than the already existing ones. The mobile phase used was a combination of Methanol, Acetonitrile, Water in the ratio of 60:20:20 respectively. This mobile phase was used along with 3ml of Trifluoro acetic acid buffer (0.1%v/v). Specifications of the method include XTerra C₁₈ Column, Flow rate of 0.5ml/min, Run time of 10mins, ambient temperature. Symmetric peak maxima was obtained and Retention time was found to be 2.085mins. The developed method can be considered as a very Economical method as the Retention time obtained is least when compared to the previously published methods for the Estimation of Rupatadine. Problems like Fronting, Tailing, Peak asymmetry were reduced due to the addition of Trifluoro acetic acid buffer (3ml), which is a Novel approach. The developed method was validated as per ICH Guidelines. R²  was found to be 0.999. LOD and LOQ values were calculated and found to be 2.142 and 9.92 respectively.  %Recovery was found to be 100.89% and %RSD was found to be 0.2. Standard Curves were linear over the concentration range of 15-75 µg/ml. Validation results serve as an authentic proof that the developed method is Reliable. Hence, this method is considered as a Novel, Reliable and Economic method. Thus, this method can be preferred for the routine analysis of Rupatadine in bulk and Pharmaceutical dosage forms.
Keywords: Rupatadine, RP-HPLC, Method development, Validation, ICH guidelines