Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ASSESSMENT OF CLOMIPHENE CITRATE AND N-ACETYL CYSTEINEIN MIXED TABLET DOSAGE FORM BY RP-UPLC

Chanduluru Hemanth Kumar*, G. Uma, Santha Arcot

ABSTRACT

An advancement design and validation for simultaneous assessment of N-ACETYL CYSTEINE (NAC) and CLOMIPHENE CITRATE (CPC) in merged tablet dosage form by UPLC. The column used in determination was C18 thermo fisher (50mm x 4.6 mm x 3μm), mobile phase comprising ofPotassium phosphate buffer: methanol: acetonitrile in the ratio of 40:52:08 v/v/v. the flow rate and injection volume were 0.2μL-1 and 1 μL respectively. The detection wave length was set at 233nm, the retention time was about 1.7 minutes and 2.7 minutes for NAC and CPC of a total run time of 5 minutes, linearity of the method was linear over the range of 96.072 to 144.048μg/ml of NAC and 8.073 to 12.01μg/ml for CPC respectively with a correlation of 0.9998 and 0.9999 for simultaneous assessment for NAC and CPC thus the method was fast, simple, elegant and less time consuming method.

Keywords: N-Acetyl cysteine, clomiphene citrate, RP-UPLC.