Mon, 18 Dec 2017

Two Novel Validated RP-HPLC and UV Spectrophotometric Methods for Estimation of Apixaban in Bulk and Pharmaceutical Dosage Forms

Rambabu Katta1,2,*, Cherukuru Nagaraju1, Ramasrinivas1, G N Rao 2

1. APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71&72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad – 502 329, Telngana, India.

2. Department of Inorganic and Analytical Chemistry, Andhra University, Visakhapatnam-530 003, Andhra Pradesh, India.


ABSTRACT

Two novel methods having requisite precision, accuracy, specificity and robustness were developed and validated for quantitative determination of Apixaban in pharmaceutical dosage forms. The first method was based on isocratic reverse phase liquid chromatography using Sunfire C18, 150mm×4.6mm, 5µ and mobile phase consists of Buffer: acetonitrile (60:40) at a flow rate 1ml/min and detection was achieved photodiodide array detector set at 280 nm. The response was linear range of 5-50 µg/ml (R2 =0.9998). The second spectrophotometric method involves detection at 280 nm. The calibration curve range between 5-50 µg/ml (R2 =0.9999). Validation of method was carried out fulfilling ICH guidelines. Both the methods were applied without any interference from excipients, for determination of drug in coated tablets. It is suggested that the proposed HPLC and UV spectrophotometric methods could be used routine quality control and dosage form assay of Apixaban.

Keywords: HPLC, UV Spectrophotometry, Apixaban, Method development, Validation.


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