DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF APIXABAN AS BULK DRUG

Mrinalini C. Damle; Swapnil S. Waghmare; PURUSHOTAM SINHA

doi:10.22159/ijpps.2019v11i5.28071

Authors

Mrinalini C. Damle Department of Quality Assurance, AISSMS College of Pharmacy, Savitribai Phule University, Kennedy Road, Near RTO, Pune 411001, Maharashtra, India
Swapnil S. Waghmare Department of Quality Assurance, AISSMS College of Pharmacy, Savitribai Phule University, Kennedy Road, Near RTO, Pune 411001, Maharashtra, India
PURUSHOTAM SINHA Department of Quality Assurance, AISSMS College of Pharmacy, Savitribai Phule University, Kennedy Road, Near RTO, Pune 411001, Maharashtra, India

DOI:

https://doi.org/10.22159/ijpps.2019v11i5.28071

Keywords:

Apixaban, HPTLC, Stability indicating method

Abstract

Objective: To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban.

Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F₂₅₄ using toluene: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm.

Results: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100-500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/bandand35.33ng/band, respectively.

Conclusion: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban.

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Author Biography

Mrinalini C. Damle, Department of Quality Assurance, AISSMS College of Pharmacy, Savitribai Phule University, Kennedy Road, Near RTO, Pune 411001, Maharashtra, India

Professor,

Quality Assurance Department

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