Method Development and Validation of Alcaftadine Drug in Bulk and Dosage Form by RP-HPLC

Abstract

RP-HPLC method until now no analytical method by RP-HPLC was reported for its determination in bulk drug and in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, suitable and robust reversed-phase high performance liquid chromatography method was developed and validated for the determination of Alcaftadine in bulk drug and in dosage form. In RP-HPLC method, Water: Methanol 0.1% OPA. (80:20 %V/V) was used as mobile phase, at a flow rate of 1.0 ml/min, on RP-HPLC system containing UV- detector with Openlab Ezchrom workstation Software with Water Kromasil C18 column (250 mm x 4.6mm ID; 5μm) & column oven temp is 40ºC. The Wavelength was carried out at 282 nm. The method gave suitable retention time i.e. 8 min for Alcaftadine. The results of analysis in the method were validated in terms of Filter study, Solution stability, specificity, Linearity, accuracy and range, precision (Repeatability and intermediate precision), limit of detection, limit of quantification and robustness. A simple and precise method was developed for the assay of Alcaftadine in bulk drug and in Dosage form. The method need regular reagents for doing analysis and also less time consuming, it can be performed routinely in industry for routine analysis of bulk drug and marketed product of Alcaftadine.