Analytical Method Development and Validation of Carbimazole by Using RP-HPLC on Bulk Drug and Marketed Formulation

Abstract

Analytical Method Development and Validation of Carbimazole by Using RP-HPLC on Bulk Drug and Marketed Formulation

The goal of the present study was to develop and validate of an analytical method for the evaluation of Clotrimazole in bulk form. UV-VIS spectroscopic technique was used for the estimation of Clotrimazole. Organic solvents and chemicals were used as trial diluents. The selection of the diluents was carried out on the basis of solubility and stability factors upon which drug was fully solubilised and stable for sufficient time. The drug was slightly soluble in water and acetonitrile, Soluble in Methanol and Alcohol. Clotrimazole showed absorption maxima (λ max) at 263 nm. The recovery studies were established the accuracy of the proposed method and the results were validated as per ICH guidelines. Linearity was obtained by concentration versus absorbance for Clotrimazole with correlation coefficient rê??0.999. Robustness of the method was calculated as the % RSD for peak area was calculated which should be less than 2%.The LOD and LOQ were calculated as 0.000228 (μg/mL), 0.00775 (μg/mL) respectively. The result analysis was validated statistically and recovery studies confirmed the accuracy and precision of the proposed method. The developed method can effectively be applied for the quality control analysis and determination of Clotrimazole in tablet dosage form.

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