IJFANS International Journal of Food and Nutritional Sciences

ISSN PRINT 2319 1775 Online 2320-7876

Stability Indicating Method Development and Validation for the Simultaneous Estimation of Encorafenib and Binimetinib In Bulk and Pharmaceutical Dosage Form by Uplc

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Mohammed Azeemuddin,Hemanth Kumar Sharma,Mohammad Zubair Baba

Abstract

The objective of the present investigation has been to develop a simple, Accurate, precise method for the simultaneous estimation of the Encorafenib and Binimetinib and its application to its pharmaceutical dosage forms. Chromatogram was run through HSS C18 100 x 2.1 mm, 2m. Mobile phase containing 0.01N Kh2po4: Acetonitrile taken in the ratio 70:30 was pumped through column at a flow rate of 0.3 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 248 nm. Retention time of ERN and BMN were found to be 1.182 min and 1.804. %RSD of the ERN and BMN were and found to be 0.6 and 0.6 respectively. %Recovery was obtained as 99.72% and 99.77% for ERN and BMN respectively. LOD, LOQ values obtained from regression equations of ERN and BMN were 0.24, 0.74 and 0.03, 0.08 respectively. Regression equation of ERN is y = 26691x + 7831.5 and y = 54983x + 1850.4 of BMN. Retention times were decreased and that run time was decreased. The validation of method was carried out utilizing ICHguideliness.so this newly developed method for the estimation of ERN and BMN was found to be simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable and cost effective and it can be applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutical and bio equivalence studies and in clinical pharmacokinetics studies in near future. The method developed was simple and economical that can be adopted in regular Quality control test in Industries

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