Abstract
DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR ESTIMATION OF DABIGATRAN ETEXILATE MESYLATE

Yeragodala Narendra Reddy and Jadi Sreeramulu*

ABSTRACT

The main objective of the study was to develop RP-HPLC method development and validation of the Dabigatran Etexilate Mesylate in the pharmaceutical dosage form. The technique was developed and thoroughly validated based on ICH (International Conference on Harmonization) guidelines. The validation process was done by precision, linearity, robustness studies, accuracy, Limit of Detection, Limit of quantification and degradation studies. The robustness studies were observed by making variations in the mobile phase, temperature, and flow rate. The developed RP-HPLC method achieved good precision and accuracy. The developed and validated method was suitable for analysis of Dabigatran Etexilate Mesylate.

Keywords: Dabigatran Etexilate Mesylate, RP-HPLC, Method Development and Validation.


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