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 (225 nm) and mobile phase composition [MeOH:2-propanol:phosphate buffer (50 mM, pH 5.5), 48:9:43 (v/v/v), 1 mL min−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.
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