Analytical method development and validation of Drotaverine Hydrochloride and Aceclofenac in bulk and pharmaceutical dosage forms by UV-Spectrophotometer

New simple, precise, rapid and reproducible UV-spectrophotometric method has been developed for the estimation of Drotaverine Hydrochloride and Aceclofenac in both bulk and tablet formulation. Drotaverine and Aceclofenac in combined tablet formulation were estimated by using the multicomponent mode at 307 nm for Drotaverine and 276 nm for Aceclofenac in their solution in ethanol: distilled water in the ratio of 50:50 (v/v %), With correlation coefficient of 0.999 for the both the drugs. The Beer’s law obeyed the concentration range of 4-40 μg/mL for Drotaverine and 5-40 μg/mL for Aceclofenac. Mean recovery of 99.54% for Drotaverine and 98.23% for Aceclofenac signifies the accuracy of the method. This method was validated with respect to linearity, accuracy (recovery), precision, Limit of detection (LOD) and limit of quantification (LOQ) as per ICH guidelines and successfully applied for the estimation of Drotaverine Hydrochloride and Aceclofenac in commercially available tablet dosage form.

Author(s): Ram Babu Durgam, Sireesha. D, Dr. V. V. L. N Prasad, Dr. Prakash V Diwan

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