Journal of Chromatography & Separation Techniques
Open Access
ISSN: 2157-7064
ISSN: 2157-7064
Jain R
Sagar
India
Research Article
Method Validation for Stability Indicating Method of Related Substance in Active Pharmaceutical Ingredients Dabigatran Etexilate Mesylate by Reverse Phase Chromatography
Author(s): Dare M, Jain R and Pandey ADare M, Jain R and Pandey A
To develop the stability indicating, highly accurate precise and linear method for related substance of the Dabigatran through the reverse phase high performance liquid chromatography and it is validated as per the current ICH guideline. The optimize method uses a reverse phase column, Poroshell 120 EC -18 (150 mm × 4.6 mm, 2.7μ), Mobile Phase of hexane-1 Sulfonic acid sodium salt monohydrate (6.5 ± 0.05) and Methanol through gradient flow rate of 0.6ml/min. Keeping the column at temperature 30°C and using the sample amount 10 μL at 5°C and detected all the impurities at 230 nm by the UV detector. In the developed method, elution of Dabigatran was at 26.9 min and all the eluted Impurities were well separated and met the system suitability criteria. The precision is exemplified by relative standard deviation of 0.40%. Method percentage mean recoveries of all .. Read More»
DOI:
10.4172/2157-7064.1000263
