Research Articles

2018  |  Vol: 4(5)  |  Issue: 5 (September- October)  |  https://doi.org/10.31024/ajpp.2018.4.5.23
Quantitative determination and validation of novel derivative spectrophotometric method for estimation of Ivabradine hydrochloride in bulk and marketed formulation

Prajakta Gopinath Thete1*, Ravindranath  Bhanudas  Saudagar2

1Department of Quality Assurance Techniques. R. G. Sapkal College of Pharmacy, Anjaneri, Nashik – 422213, Maharashtra, India

2Department of Pharmaceutical Chemistry. R. G. Sapkal College of Pharmacy, Anjaneri, Nashik – 422213, Maharashtra, India

*Address for Corresponding Author

Prajakta Gopinath Thete

Department of Quality Assurance Techniques. R. G. Sapkal College of Pharmacy, Anjaneri, Nashik – 422213, Maharashtra, India

Abstract

Objective: A simple, rapid, highly sensitive, selective, specific, robust UV spectrophotometric method has been developed and validated for the estimation of Ivabradine HCL in bulk and pharmaceutical dosage form. Material and Methods: Spectroscopic determination was done by zero order and first order derivative spectroscopic method by using water an ideal solvent and λ max was found to be 286nm. Beer’s Lambert’s Law was obeyed within the range of 10-30μg/ml for Zero, First order method. Results: The method was validated according to ICH for the validation parameters accuracy, precision, LOD, LOQ, specificity. The correlation coefficient (r2) of method was found to be 0.9997 and 0.998 for zero and first order method respectively. The intra-day and inter-day precision and accuracy values for both the methods were found to be less than 2% RSD. Conclusion: The Proposed UV spectroscopic methods have been successfully applied to the commercial tablets without any interference of excipients. The method can be used for the routine analysis in industry of Ivabradine HCL in bulk and tablet dosage forms.  

Keywords: Ivabradine hydrochloride, UV spectroscopy, Derivative Spectroscopy, validation, first order derivative

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