Experimentally designed, validated hplc simultaneous determination of pridinol and diclofenac in their combined pharmaceutical formulations, which allows limiting diclofenac related compound A

Abstract

The development and validation of an HPLC method for the determination of pridinol and diclofenac in their combined formulations and the simultaneous limit testing of diclofenac related compound A is described. The separation was performed on a C18 column. Experimental design and response surface strategies were employed for optimizing detection wavelength (225nm) and mobile phase composition [MeOH:2-propanol:phosphate buffer (50mM, pH 5.5), 48:9:43 (v/v/v), 1mLmin-1], and for validation purposes. The method was successfully applied to the quality control of commercial brands of tablets and capsules. Found impurity levels were below 0.1% (LOQ=0.02%). Stressed samples were also evaluated.