Analytical Method Development and Validation of Denaverine Hydrochloride in Bulk and Injectable Pharmaceutical Dosage Form

Authors: Ravindar Bairam, Vinay Raj Vangala, P. Balakrishanaiah, Manjunath S.Y

Country: India

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Abstract: A new, simple, accurate, precise and rapid Reverse-Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and subsequently validated for the estimation of Denaverine HCl in bulk and injection dosage form, which is used in the treatment of antispasmodic drug in Veterinary medicine. The proposed method is based on the separation of the drugs in reversed-phase mode using Symmetry C18 Column (4.6 x 150mm, 5 m, Make
: XTerra) The optimized mobile phase was disodium hydrogen phosphate buffer (pH 3.5): Acetonitrile (30:70 %v/v). The flow rate was at 0.6 mL/min and UV detection at 306 nm. The retention time was 3.2 min for Denaverine HCl. The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 10-50μg/mL for Denaverine HCl. Mean percent recovery of samples at each level for both drugs were found to be 101.3 %v/v for Denaverine HCl. In terms of Linearity, Precision, Accuracy, Recovery, Limit Of Detection (LOD), And Limit Of Quantitation (LOQ), the developed technique was within limit as per ICH guidelines. The proposed method can be successfully applied in the quality control of bulk and injectable pharmaceutical dosage forms.

Keywords: Denaverine hydrochloride, validation, estimation , HPLC.

Paper Id: 231858

Published On: 2025-01-20

Published In: Volume 13, Issue 1, January-February 2025

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