Original Articles
Murali Krishna Prasad Vallabha
Abstract
A new, rapid, specific and sensitive Ultra Performance Liquid Chromatographic (UPLC) method with gradient elution was developed and validated for the determination of related substances in Fenoprofen calcium. The successful separation of Fenoprofen calcium and its impurities was achieved using BEH C18 column (Size: 100 × 2.1 mm; 1.7 μm particle size) column maintained at 30°C with mobile phase consisting of Water : Acetic acid (980:20) as Mobile phase-A (MP-A) and Acetonitrile : Acetic acid (980:20) as Mobile phase-B (MP-B) in a gradient programme. The mobile phase flow rate was 0.3 ml/min and the detection wavelength was 270 nm. The retention time of Fenoprofen calcium and its impurities in the present method was comparatively less than the reported HPLC methods, offering less time consuming, minimum usage of chemical reagents and fast analytical method. As part of the method validation, specificity, limit of detection (LOD), limit of quantification (LOQ), linearity, accuracy, precision, robustness and ruggedness were determined.