Author： Vignaduzzo Silvana Castellano Patricia Kaufman Teodoro
Publisher： Taylor & Francis Ltd
ISSN： 1082-6076
Source： Journal of Liquid Chromatography & Related Technologies, Vol.33, Iss.19, 2010-01, pp. : 1720-1732
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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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