Experimentally Designed, Validated HPLC Simultaneous Determination of Pridinol and Diclofenac in their Combined Pharmaceutical Formulations, which Allows Limiting Diclofenac Related Compound A

VIGNADUZZO, S. E.; CASTELLANO, P. M.; KAUFMAN, T. S.

JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES

TAYLOR & FRANCIS INC

Lugar: Nueva York; Año: 2010 vol. 33 p. 1720 - 1732

1082-6076

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), 1mL min1], 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% (LOQ¼0.02%). Stressed samples were also evaluated.