Development and Validation of RP-HPLC Method for Simultaneous Estimation of Bromhexine and Erythromycin in Bulk and Pharmaceutical Dosage Forms

Abstract

A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for simultaneous estimation of Bromhexine and Erythromycin in tablet dosage forms. The chromatographic separation was carried out on Hypersil BDS C18 column (150 mm x 4.6 mm I.D., 5 µm particle size) with a mixture of 0.01N phosphate buffer and acetonitrile in the ratio of 35:65 v/v as a mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 224 nm. The retention times were 4.619 minutes and 2.329 minutes for Bromhexine and Erythromycin respectively. Calibration plots were linear (r2=0.999 for both Bromhexine and Erythromycin respectively) over the concentration range of 2-12 µg/mL for Bromhexine and 62.5-375 µg/mL for Erythromycin. The method was validated for linearity, precision, accuracy and robustness. The proposed method was successfully used for simultaneous estimation of Bromhexine and Erythromycin in tablet dosage forms. Validation studies revealed that the proposed method is specific, rapid, reliable and reproducible. The high % recovery and low % RSD values confirm the suitability of the proposed method for routine quality control analysis of Bromhexine and Erythromycin in bulk and tablet dosage forms. Keywords: Bromhexine, Erythromycin, Estimation, HPLC