Abstract

SPECTROMETRIC DISSOLUTION METHOD FOR DABIGATRAN ETEXILATE MESYLATE CAPSULES

N. J. R. Hepsebah* and A. Ashok Kumar

ABSTRACT

Spectroscopic dissolution method is developed for dabigatran etexilate mesylate capsules and is validated as per ICH guidelines. The developed method is simple, precise and accurate. The optimized dissolution conditions include, 0.01N HCl as dissolution media, apparatus as USP Type 1 Basket, rpm as 100, dissolution media temperature as 37±0.5ºC, dissolution volume as 500ml, dissolution time point as 30mts, detection wavelength at 325nm,working concentration of standard and sample as 5μg/ml .The developed method resulted in Dabigatran etexilate exhibiting linearity in the range 1.25-10μg/ml. System precision and intra-day precision is exemplified by relative standard deviation of 0.945% and 2.21% respectively. Method was found to be rugged/inter day precise as %RSD was found to be 3.54. Percentage Mean recovery was found to be greater than 80% at all the three levels by absolute method during accuracy studies. LOD and LOQ for Dabigatran etexilate were found to be 216ng/ml and 656ng/ml respectively. Hence it can be concluded that effective dissolution method by uv-vis is developed and validated as per ICH guidelines which can be applicable in various pharmaceutical industries.

Keywords: Dabigatran Etexilate, Dissolution, ICH guidelines, Validation.