Abstract
A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HPLC method was successfully applied to the analysis of both Apixaban drug substance and drug product. The chromatographic separation was achieved on a Sigma-Aldrich’s Ascentis Express® C18 (4.6 mm × 100 mm, 2.7 μ) HPLC column with a runtime of 40 min. Mobile phase-A and mobile phase-B were phosphate buffer and acetonitrile respectively. The column oven temperature was set at 35°C and photodiode array detector was set at 225 nm. Nine process related impurities (Imp-1 to Imp-9) have been detected in test sample of Apixaban by using newly developed RP-HPLC method. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating nature of the developed RP-HPLC method. The developed method was validated as per ICH guideline and found to be specific, precise, sensitive and robust.
Highlights
Apixaban is an anticoagulant drug chemically known as l-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-l-yl) phenyl]-4,5,6,7-tetrahydro-lH-pyrazolo[3,4-c]pyridine-3-carboxamide and sold under the brand name “Eliquis” to treat the people with atrial fibrillation to lower the risk of stroke caused by a blood clot
“Eliquis” is used after hip or knee replacement surgery to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs [1]-[6]
Optimization of HPLC Chromatographic Conditions Using Core Shell Columns The objective of method development was to separate Apixaban and its process and degradation related impurities (Imp-1 to Imp-9) with shorter run time to increase the throughput at quality control laboratories, good resolution and peak shapes
Summary
Apixaban is an anticoagulant drug chemically known as l-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-l-yl) phenyl]-4,5,6,7-tetrahydro-lH-pyrazolo[3,4-c]pyridine-3-carboxamide and sold under the brand name “Eliquis” to treat the people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot It was invented by Aderis pharmaceuticals and was developed jointly by Pfizer and Bristol-Myers Squibb. To the best of our knowledge, no method on core shell column has been reported for the determination of Apixaban and its potential process related impurities in the drug substance and drug product for regular analysis and stability studies in quality control laboratory. The core-objective of this research work was to develop a fast, precise, sensitive and stability-indicating RP-HPLC method for the determination of process and degradation related impurities of Apixaban. The developed method was successfully validated according to the USP Validation of Compendial Procedures and ICH guidelines [17] [18]
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