ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE IN PURE AND DOSAGE FORMS BY USING RP-HPLC METHOD
Sk. Karishma*, Ch. M. M. Prasada Rao and D. Dhachinamoorthi
ABSTRACT
A simple, precise, analytical method was developed for Dabigatran Etexilate in pure and dosage forms by using RP-HPLC method analysis initial chromatographic conditions Mobile phase Buffer: ACN: Water in gradient method, Zodiac, C18, 100×4.6mm, 3.5? column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with UV- VIS detector in system and it showed maximum absorbance at 310 nm. As the mobile phase content is allowed in gradient performance Dabigatran Etexilate got eluted with good peak symmetric properties. The retention time for Dabigatran Etexilate was found to be 4.767min respectively. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 50%, 100% and 150 % levels, R2 value was found to be as 0.999. By using above method assay of marketed formulation was carried out, 99.92% for Dabigatran Etexilate was present. Full length method was not performed; if it is done this method can be used for routine analysis of Dabigatran Etexilate.
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