Development and Validation of Novel Analytical Method for Estimation of Diltiazem HCL
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Abstract
A novel, simple, accurate and precise Zero order derivative spectroscopic method was developed and validated for the estimation of Diltiazem HCl in bulk and Pharmaceutical dosage forms and has an absorption maximum at 193 nm in 0.05N Sulphuric acid. The Linearity was found to be in the concentration range of 3-18 μg/ml and the correlation coefficient was found to be 0.998 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.0971x + 0.0268 .The % recovery values were found to be within 99.3 -102.06 % showed that the method was accurate. The LOD and LOQ were found to be 0.222 and 0.675μg/ml, respectively. The % RSD values were less than 2. The method has been validated according to ICH guidelines for linearity, accuracy, precision, ruggedness, Limit of detection and limit of quantitation. Proposed method was successfully applied for the quantitative estimation of Diltiazem HCl in bulk and pharmaceutical dosage form.
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