Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF CEPHALEXINE AND BROMHEXINEIN CAPSULE DOSAGE FORMS

V. Mounika*, V. Mani Sarika, Nagaraju Pappula and G. Indira Priyadarshini

ABSTRACT

A simple and reproducible Reverse Phase High-Performance LiquidChromatography (RP-HPLC) method was developed and validated inaccordance with ICH guidelines for the simultaneous estimation ofCephalexin and Bromhexine in a marketed formulation. The methodemployed a Kromasil C8 column (4.6 x 250 mm, 5 μm) with 0.1%OPA: Acetonitrile (45:55) as the mobile phase, and the detectionwavelength was set at 215 nm. Method validation was performed forspecificity, system suitability, accuracy, linearity, precision,ruggedness, and robustness. The system showed no interference fromplacebo or blank and provided acceptable values for theoretical plates,tailing factor, retention time, and peak area. Linearity was confirmedwithin the range of 1-6 μg/ml for Bromhexine and 62.5-375 μg/ml forCephalexin, with %RSD values of 0.6 and 0.5 for Bromhexine, and 0.5and 0.4 for Cephalexin, indicating precision. Accuracy was within the98%-102% recovery range, confirming the method's reliability. Themethod demonstrated ruggedness across different systems and robustness under varying flowrates and temperatures. This validated method is suitable for routine analysis of Cephalexinand Bromhexine in combined dosage forms.

Keywords: Reverse Phase High-Performance Liquid Chromatography (RP-HPLC), Cephalexin, Bromhexine, specificity, system suitability, accuracy, linearity, precision, ruggedness, and robustness.