Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF PYRILAMINE MALEATE AND DICLOFENAC SODIUM

Kavya R.*, Chandrashekhar Javali and Nandakumar R.

ABSTRACT

A simple and sensitive reverse phase high performance liquid chromatographic method has been established for the simultaneous estimation of Pyrilamine maleate and Diclofenac sodium using Acetonitrile: 1 % Ortho phosphoric acid in milli pore water (pH 2.5) (80:20 v/v) at flow rate of 0.8mL/min. Zodiac C18 column (250×4.6mm, 5μ) column provided chromatographic separation of analyte followed by detection with UV at 280nm. The retention time of Pyrilamine maleate and Diclofenac sodium was found to be 2.5 min and 5.8 min respectively. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 15-240 μg/mL for pyrilamine maleate and 5-80 μg/mL for Diclofenac sodium. The mean values of the correlation coefficient were 0.9996 for Pyrilamine maleate and 0.9997 for Diclofenac sodium. The method was validated to fulfil international conference on harmonization (ICH) requirements with parameters such as specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness and ruggedness.

Keywords: Pyrilamine maleate, Diclofenac sodium, RP-HPLC, Simultaneous estimation. ICH guidelines.