Abstract

METHOD DEVELOPMENT AND VALIDATION OF BAMBUTEROL IN PHARMACEUTICAL FORMULATION BY RP-HPLC METHOD

P. Pavan Kalyan*, M. Srikanth and M. Prasadarao.

ABSTRACT

A rapid, simple, precise, Cost-effective reverse phase high performance liquid chromatographic (RP-HPLC) method had been developed and validated for the estimation of Bambuterol in bulk pharmaceutical dosage form. The chromatographic separation of Bambuterol was developed on a Waters, X-bridge C-18 column with 100 x 4.6 mm i.d. and 5 μm particle size, using UV detection at 217nm. Mobile phase consisting of Acetonitrile:Phosphate buffer pH 5.0 (25:75 v/v), with flow rate was 1ml / min. Chromatogram showed the main peak at a retention time of 2.349 ± 0.02 min. The linearity was found in the concentration range of 5-15 (μg/ml). The Correlation coefficient was 0.9998. The limit of detection and limit of quantitation for estimation of Bambuterol was found to be 1.6 (μg/ml) and 5.04 (μg/ml) respectively. Recovery of Bambuterol was found to be in the range of 98.73-100.62 %. The Proposed method can be used for the routine analysis of Bambuterol in pharmaceutical dosage form.

Keywords: Bambuterol, Method development, validation, RP-HPLC, ICH guidelines.