A simple, selective, rapid, precise and economical reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Tramadol hydrochloride and Diclofenac sodium from pharmaceutical formulation. The method was carried out on a C18 (25 cm x 4.6 mm i.d., 5 μ) column with a mobile phase consisting of Methanol: water (adjusted to pH 3.0 using orthophosphoric acid) in the ratio of 80:20 v/v with 0.25% (v/v) triethyl amine (TEA).The retention time of Tramadol hydrochloride and Diclofenac sodium was 3.2min and 6.1min respectively with the flow rate of 1 mL. min-1. Eluents were detected at 273 nm. The linear regression analysis data for the linearity plot showed good linear relationship with correlation coefficient value for Tramadol hydrochloride and Diclofenac sodium were R2 = 0.9997 and R2 = 0.9999 in the concentration range of 5-50 µg. mL-1 , 10-70 µg. mL-1 respectively. The relative standard deviation for intra-day precision was lower than 2.0%. The method was validated according to the ICH guidelines. The method was also found to be robust. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.
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