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Abstract

SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF CLOPIDOGREL BISULPHATE RESIDUE IN SWAB SAMPLES

*Vivek B. Rajendra, Onkar J. Deshmukh, Pavan Kumar Rawat, Bhushan S. Gulecha, Shailendrasingh Khushwaha, Shyam V. Ghadlinge

Shreya Life Sciences Pvt. Ltd. Waluj, Aurangabad-Maharashtra, India.

ABSTRACT

A simple, sensitive, rapid, precise, cost effective and reproducible UV spectrophotometric method has been developed for estimation of Clopidogrel residue in swab samples to validate cleaning procedure. The swabbing procedure was optimized in order to obtain suitable recovery from stainless steel surface using Tex wipe polyurethane swab stick. A mean recovery of 94.9733% was obtained when swab dipped in methanol were used. Beer’s law is valid in concentration range of 2.5-20 μg/ml and UV detection was done at 217nm. The proposed method was validated in terms of linearity, precision, accuracy, limit of detection, limit of quantification. The proposed method was found to be accurate and precise for routine estimation of Clopidogrel in quality control laboratories.

Keywords: Clopidogrel, Swab testing, Spectrophotometric, Cleaning validation.


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