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 to be in between 1.31 to 1.73 whereas the inter-day precision values were in between 1.59 to 2.00. The variation (% RSD) during the robustness and ruggedness studies of the proposed UV–Visible spectrophotometric method was found be below 2%. The limit of detection (LOD) and limit of quantitation (LOQ) of the proposed UV–Visible spectrophotometric method was found to be 0.1008 μg/mL and 0.3058 μg/mL respectively, ensuring adequate sensitivity for routine quality control analysis. Proposed method was successfully used for the estimation of Dexlansoprazole in formulation as well as bulk.
Conclusion: A simple, precise, yet cost-effective UV-visible spectrophotometric method was successfully developed for the estimation of Dexlansoprazole. The method utilized a solvent with an economical percentage of the organic phase in aqueous media. The validated UV-Visible method can be efficiently employed for estimating Dexlansoprazole.
Keywords:
Dexlansoprazole, UV-Visible spectrophotometry, ICH guidelinesDOI
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