Abstract

“ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BROMOCRIPTINE MESYLATE AND METFORMIN HYDROCHLORIDE WITH DOE APPROACH”

Jainul Bhayji, Falguni Tandel*, Nikita Patel

ABSTRACT

A sensitive HPLC technique with ultraviolet detection (HPLC– UV) was developed and Optimised with DOE approach using BOX-Behnkan Design then validated for the quantitative determination of Bromocriptine mesylate and Metformin HCl. Chromatography was performed on syncronis column C18 (250×4.6 mm i.d., 5 μm particle size); using a mobile phase composed of methanol: potassium dihydrogen ortho phosphate of pH 4.0 (85:15 v/v) pumped at a flow rate of 1.0 mL/min. The detector was operated at 252nm. The retention times for Bromocriptine mesylate and Metformin HCl were 4.92min and 2.52min respectively. The linearity of Bromocriptine Mesylate and Metformin HCl was within the concentration range of 0.2–1.0 μg/mL and 12.50 μg/mL-62.50 μg/mL with limit of detection 0.031 μg/mL and 4.22 μg/mL respectively. The intra-day precision results, expressed by relative standard deviation values, were lower than 0.2572% and 0.574% respectively. The validated method has been successfully applied to the analysis of Bromocriptine mesylate and Metformin HCl in Synthetic Mixture with no interference from the excipients.

Keywords: Bromocriptine mesylate; Metformin HCl; HPLC; DOE: Synthetic Mixture.