DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF DACLATASVIR DIHYDROCHLORIDE IN TABLET DOSAGE FORM
Pavithra V.*, Jose Gnana Babu C. and Sowmya H. G.
Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Daclatasvir dihydrochloride in bulk and Pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 302nm in 0.1N HCl solution and Area under Curve [AUC] in absorption spectra were measured between the wavelength range 297 to 307 nm which obeys Beer’s law in the concentration range of 3-15μg/ml. The linearity study carried and regression coefficient was found to be 0.9993 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 100.61-101.04. The LOD and LOQ were found to be 0.0165 and 0.0495μg/ml. The % relative standard deviation were found less than 2. According to ICH guidelines the method has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for reliable quantification of Daclatassvir dihydrochloride in bulk form and pharmaceutical dosage form.
Keywords: Daclatassvir dihydrochloride, Area under curve spectroscopy, validation, pharmaceutical formulations.
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