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Abstract

A simple, rapid, reliable and precise reversed phase UPLC method has been developed and validated according to the regulatory guidelines for determination of carbamazepine API in bulk, which composed of isocratic mobile phase; Solution-A: 0.5mL of Triethyl amine and 0.5mL of Formic acid to 1000mL of water. Solution-B: 0.25mL of Formic acid to 1000mL of Methanol, with a flow rate of 0.3 ml/min, and column Acquity UPLC HSS CYANO 10cm x 2.1 mm, 1.8 µm, packing L10. The detection was carried out at 230 nm. The study showed that the proposed UPLC method can be used for the assessment of drug purity.


UPLC: It opened an innovative direction for liquid chromatography covering three major areas including speed, sensitivity and resolution of evaluation by means of the use of packing material with particles size less than 2 µm. The device is created to handle very high pressure experienced by the column.

Keywords

Validation, Carbamazepine API, UPLC, Assay

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