DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION APIXABAN IN BULK AND TABLETS


Hemant K. Jain, Vishal K. Nikam

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.


Keywords


Apixaban, Toluene, Methanol, Diethylamine, HPTLC

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References


Pinto DJ. Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo piperidine-1-yl) phenyl)-4, 5, 6, 7-tetrahydro-1 H-pyrazolo [3, 4-c] pyridine-3-carboxamide (Apixaban, BMS-562247), a highly potent, selective, efficacious and orally bioavailable inhibitor of blood coagulation factor Xa. J Med Chem 2007;50:5339-56.

Lassen MR. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. J Thromb Haemostasis 2007;5:2368-75.

FDA approves apixaban for stroke prevention in nonvalvular AF-Medscape; 2012.

Landge SB. Development and validation of stability indicating RP-HPLC method on core shell column for determination of degradation and process related impurities of apixaban-an anticoagulant drug. Am J Anal Chem 2015;6:539-50.

Prabhune SS, Jaguste RS, Kondalkar PL, Pradhan NS. Stability-indicating high-performance liquid chromatographic determination of apixaban in presence of degradation products. Sci Pharm 2014;82:777-85.

Katta R, Nagaraju C, Ramashrinivas, Rao GN. Two novel validated RP-HPLC and UV spectrophotometric methods for estimation of apixaban in bulk and pharmaceutical dosage forms. Am J PharmTech Res 2015;5:4.

Zhang W, Lou D, Zhang D, Zhang Y, Huang H. Determination of rivaroxaban, apixaban and edoxaban in rat plasma by UPLC–MS/MS method. J Thromb Thrombolysis 2016;42:205–11.

Schmitz E. Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants. J Thromb Haemostasis 2014;12:1636-46.

Delavenne X, Mismetti P, Basset T. Rapid determination of apixaban concentration in human plasma by liquid chromatography/tandem mass spectrometry: application to pharmacokinetic study. J Pharm Biomed Anal 2013;78-79:150–3.

Tilea I. Determination of apixaban levels in human plasma by a high-throughput liquid chromatographic tandem mass Spectrometry assay. Rev Romana Med Lab 2015;23:2-25.

Tantawy MA, El-Ragehy NA, Hassan NY, Abdelkawy M. Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product. Spectrochim Acta Mol Biomol Spectrosc 2016;159:13–20.

Vaghela D, Patel P. High-performance thin layer chromatographic method with densitometry analysis for determination of rivaroxaban from its tablet dosage form. Int J Pharm Pharm Sci 2014;6:383-6.

Rathinam S, Lakshmi KS. High-performance thin layer chromatographic method for the simultaneous estimation of camylofin dihydrochloride and mefenemic acid in a pharmaceutical tablet. Int J Pharm Pharm Sci 2014;6:585-9.

Patel DJ, Desai SD, Savaliya RP, Gohil DY. Simultaneous HPTLC determination of lopinavir and ritonavir in combined dosage form. Asian J Pharm Clin Res 2011;4:59-61.

Aher A, Jain HK. Development and validation of HPTLC method for determination of gliclazide in API and pharmaceutical dosage form. World J Pharmacy Pharm Sci 2014;4:1485-93.

ICH Harmonized-Tripartite Guidelines. Validation of Analytical Procedure: Text and Methodology. November Q2(R1); 2005.




About this article

Title

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION APIXABAN IN BULK AND TABLETS

Keywords

Apixaban, Toluene, Methanol, Diethylamine, HPTLC

DOI

10.22159/ijap.2017v9i5.20028

Date

15-09-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 5 (Aug-Sep), 2017 Page: 78-82

Online ISSN

0975-7058

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Authors & Affiliations

Hemant K. Jain
Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune 411041, Maharashtra, India
India

Vishal K. Nikam
Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune 411041, Maharashtra, India
India


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