Abstract

DEVELOPMENT AND VALIDATION OF A UPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF DICLOFENAC POTASSIUM AND CHLORZOXAZONE IN THEIR BINARY MIXTURES AND PHARMACEUTICAL FORMULATION

Fathy M. Salama, Khadiga M. Kilani, Ragab A. Said, Mohammad A. El-Dosoky Hassan A. M. Hendawy and Bilal Amer Abdel Aal*

ABSTRACT

A simple, precise, accurate and rapid isocratic reverse phase Ultra high performance liquid chromatographic method was developed for simultaneous determination of diclofenac potassium and chlorzoxazone in binary mixture and capsules dosage form. The chromatographic separation was performed on an A zorbax eclipse plus C18 column (4.6mm X 100mm, 3.5μm) using a mobile phase composed of methanol: water acidified with phosphoric acid buffer (80:19:1 by volume) running on a flow rate of 1 mL/min and the effluent was monitored at 275 nm. The proposed method was validated for linearity, accuracy, precision, specificity, LOD and LOQ. The calibration was linear over the range of 10-80 ng/mL for diclofenac potassium and 50-400 ng/mL for chlorzoxazone. The retention times were found as 1.407 and 2.44 min for diclofenac potassium and chlorzoxazone; respectively. The proposed method was validated as per ICH guidelines and successfully applied for the quantitative routine determination of DFP and CLZ in their binary mixture and pharmaceutical dosage forms.

Keywords: UPLC, Diclofenac potassium and chlorzoxazone.