Method Validation for the Quantification of Dexlansoprazole dual-delayed release capsules by RP-HPLC
Abstract
Dexlansoprazole is used in the symptomatic management associated with Gastroesophageal Reflux Disease and Erosive Esophagitis. It is a new generation proton-pump inhibitor. The main aim of this article is to develop and validate an RP-HPLC method for the estimation of Dexlansoprazole in both 20%W/W dual delayed-release pellet and dual delayed-release capsule forms 60 mg. The foundational work facilitated the validation of a newly developed RP-HPLC method for the quantitative of Dexlansoprazole. Method was achieved with Inertsil ODS C18, 100x4.6mm, 5µm at 1.0ml/min flow rate for 10min run time at 285nm. The linearity was achieved in the range of 15-120ppm with R2 value 1.000 and retention time at 4.53min. Accuracy was found to be 98-102% with a precision %RSD of 0.07. This method is designed to be simple, precise, and economical, featuring a shorter run time that makes it ideal for routine quality control applications. The validation was performed in compliance with ICH guidelines, confirming that the established method is reliable for quality control purposes.
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