Development and Validation of UV-Visible Spectrophotometric Method for Estimation of Dexlansoprazole
Abstract
Aim: The Proposed study aimed to develop and validate a simple, accurate, precise and cost-effective UV-Visible spectrophotometric method for the estimation of Dexlansoprazole in bulk as well formulation. Methods: This method for Dexlansoprazole was developed using water containing 40% acetonitrile as solvent system. After development, proposed method was validated using ICH Q2 (R1) guidelines. Dexlansoprazole solutions were scanned across the UV-visible range to identify its wavelength of maximum absorbance. The linearity of the method was established using seven calibration standards over a concentration range of 1–25 μg/mL. Three different quality control standard solutions of the Dexlansoprazole were used for establishing the accuracy and precision of the proposed method. Validity of the proposed method was established on the basis of accuracy, precision, robustness, ruggedness, limit of detection (LOD), and limit of quantitation (LOQ). Results: The Dexlansoprazole when dissolved in water containing 40% acetonitrile showed maximum absorbance at 282 nm. The developed method demonstrated excellent linearity across the concentration range of 1–25 μg/mL, with a correlation coefficient (r²) of 0.999. The intra-day accuracy of the proposed method in terms of % Difference was in the range of −2.04 to +2.63 whereas the inter-day accuracy was in the range of −2.04 to + 2.12. The intra-day precision of the proposed UV–Visible spectrophotometric method in terms of % RSD was found…
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