Manuscript Title:

DEVELOPMENT AND VALIDATION OF A HPLC METHOD SUITABLE FOR ASSAY AND DISSOLUTION TESTING IN APIXABAN TABLETS FINAL DOSAGE FORM

Author:

ASIF KHAN SHERWANI, KHALIL AHMED ZAKARIA, SHAFIQ SHEIKH, MOHSIN ALI KHAN, MOHAMMED ABDUL BARI, MOHAMMAD RIYAZ, EKTEMAL ALI ALJAZZANI

DOI Number:

DOI:10.17605/OSF.IO/FB8D2

Published : 2023-02-23

About the author(s)

1. ASIF KHAN SHERWANI - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.
2. KHALIL AHMED ZAKARIA - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.
3. SHAFIQ SHEIKH - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.
4. MOHSIN ALI KHAN - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.
5. MOHAMMED ABDUL BARI - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.
6. MOHAMMAD RIYAZ - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.
7. EKTEMAL ALI ALJAZZANI - Jamjoom Pharmaceuticals Co. Ltd, Research and development unit, Jeddah, Saudi Arabia.

Full Text : PDF

Abstract

Background: Apixaban is an anticoagulant agent that inhibits coagulation factor Xa, commercially available as coated tablets at the dosages of 2.5 and 5 mg. There is no official monograph of the formulation in the current international pharmacopoeias. Objective: This paper presents a simple, specific and precise high-performance liquid chromatographic method for determination of Apixaban in solid dosage form. Method: The mobile phase consists of Acetonitrile – Buffer (320 + 680, v/v). A column containing octadecylsilane chemically bonded to porous silica particles (Chromosil® 100 ODS 150 x 4.6 mm, 5 µm) was used as stationary phase. Detection was performed using a variable wavelength ultraviolet-visible detector set at 230 nm for Apixaban. Solutions were injected into the chromatograph under isocratic condition at a constant flow rate of 1.0 mL/min. Results: The method demonstrates acceptable accuracy and precision and a wide linearity range. Linearity was observed in the range 25-150 µg /mL for Apixaban (r2 =0.999) for drug estimated by the proposed method was in good agreement with the label claim. The accuracy of the methods was assessed by recovery studies at three different levels. Specificity experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD of less than 2. Conclusion: The HPLC method for Assay and dissolution for Apixaban was developed and validated as per guideline and it is found to be precise, specific, accurate and robust.


Keywords

All statistical data proves validity of the methods and can be used for routine analysis of quality control and stability studies in pharmaceutical dosage form.