DETERMINATION OF 2-CYANO-4'-BROMOMETHYL BIPHENYL GENOTOXIC IMPURITY IN IRBESARTAN DRUG SUBSTANCES USING HPLC TECHNIQUE

S. Senthil Kumar; Ritesh Kumar Srivastava; V. Srinivas Rao

doi:10.22159/ijpps.2016v8i12.14682

Authors

S. Senthil Kumar Faculty of Pharmacy, Pacific Academy of Higher Education and Research University, Udaipur 313004, Rajasthan, India
Ritesh Kumar Srivastava Analytical Research and Development, Macleods Pharmaceuticals Limited, R&D Center, Mumbai 400059, India
V. Srinivas Rao Faculty of Pharmacy, Pacific Academy of Higher Education and Research University, Udaipur-313004, Rajasthan, India

DOI:

https://doi.org/10.22159/ijpps.2016v8i12.14682

Keywords:

Impurity, HPLC, TTC, Validation, ICH guidelines

Abstract

Objective: The objective of present study was to develop and validate a specific and sensitive HPLC method for the quantitative determination of genotoxic impurity 2-cyano-4'-bromomethyl biphenyl present in irbesartan drug substance.

Methods: The development activity was conducted by HPLC with UV as a detector. The impurity was separated on Kromasil C18 250 x 4.6 mm, 5 Âµm analytical column with a mobile phase consisting of buffer pH 3.2 and acetonitrile in the ratio of 60:40 v/v at a flow rate 1.5 ml/min. The effluent was monitored by UV detection at 258 nm with column temperature maintained at 40 Â°C and the injection volume 30 Î¼l. Acetonitrile was selected as diluent.

Results: Validation activity was planned and completed based on the ICH guideline. The LOD and LOQ value were found to be 0.167 Âµg/g and 0.506 Âµg/g and accuracy results were well in the range 98.34 to 103.46 %. The linearity curve showed the correlation coefficient of 0.9999 and method very sensitive.

Conclusion: From validation data, it was confirmed that the developed method is specific, sensitive, linear, precise and accurate for the determination of 2-cyano-4'-bromomethyl biphenyl genotoxic impurity in irbesartan drug substances.

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