Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BROMHEXINE BY RP-HPLC METHOD

Narsu Kumari Korrapati*, Hemalatha Vongavolu, Samyuktha Vallamreddy and Aravind Perabathina

Abstract

The objective of the present work is to develop an efficient, precise, accurate, linear, simple, rapid, reproducible and sensitive RP- HPLC method for the estimation of Bromhexine in tablet dosage forms. The developed method was validated as per ICH guidelines. The HPLC method was developed using waters C18 column (250mm×4.6mm; 5μ id) and flow rate 1.0ml /min. Detection was carried out at by absorption at 226nm and injection volume is 20μl. The mobile phase used was methanol, acetonitrile and 0.1% orthophospharic acid 75:24:01. The calibration curve was linear over the range of 10- 60μg/ml. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Bromhexine in tablet dosage forms.

Keywords: Bromhexine, tablet dosage form, RP-HPLC method, validation.