Abstract
Objective: To develop a simple and sensitive, high-performance thin layer chromatographic (HPTLC) method for the quantitative estimation of apixaban in bulk and tablets.Methods: Sample of apixaban was applied on silica gel 60 F254 TLC plates under pure nitrogen stream by linomat TLC applicator. Separation was carried out by using toluene, methanol and diethylamine as a mobile phase in a ratio of 16:3:1 v/v/v. Developed TLC plates were scanned by camag TLC scanner and detection was carried out at 288 nm.Results: Rf value of apixaban was found to be 0.4. The linearity was found from 50 to 350 ng/spot. The mean percentage recovery was found to be 85.66with % RSD of 0.79.Conclusion: The present study represents first HPTLC method that deals with the estimation of apixaban. Validation results indicated that the developed method is simple, rapid, accurate, specific, sensitive and precise. The developed method was validated as per ICH Q2 (R1) guideline by studying various validation parameters like accuracy, precision, specificity, assay, LOD and LOQ. It can be concluded that the method can be used in routine analysis of apixaban in tablet dosage form.
Highlights
Apixaban is chemically 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo piperidin-1-yl) phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo [3,4c]pyridine-3-carboxamide [fig. 1]
This paper presents development and validation of a simple, accurate and precise high-performance thin layer chromatographic (HPTLC) method for estimation of apixaban in bulk and tablets
Precoated silica gel 60 f254 TLC (e-merck, Germany) plates (10x10 cm) were used as stationary phase and a mixture of toluene, methanol and diethylamine was used as mobile phase
Summary
Apixaban is chemically 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo piperidin-1-yl) phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo [3,4c]pyridine-3-carboxamide [fig. 1]. FDA approved apixaban (eliquis, bristol-myers squibb/pfizer) on december 28, 2012 for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) [3]. Apixaban is not an official drug in any Pharmacopoeia. Literature survey reveals that some methods have been reported for their determination of apixaban by HPLC [4,5,6] and hyphenated techniques such as UPLC–MS/MS [7,8], LCMS [9,10], GCMS [11], either alone or in combination. There is no HPTLC method available yet for estimation of apixaban in tablets. This paper presents development and validation of a simple, accurate and precise HPTLC method for estimation of apixaban in bulk and tablets
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