Abstract

Ceema Mathew¹_, M. Ajitha², P. R. Sathesh Babu¹

DOI : http://dx.doi.org/10.13005/ojc/300453

The present work describes the development of a stability indicating high performance liquid chromatographic (HPLC) method for the determination of Balofloxacin as bulk drug and as pharmaceutical formulation. The drug was separated using Phenomenex (250 x 4.6mm, 5µm particle size) ODS column at a flow rate of 1 mLmin^-1 and a SPD 20 A UV detector to monitor the eluate at 298 nm. The isocratic method used a  mobile phase consisting of methanol and phosphate buffer of pH 6.8 in the ratio 70:30. The linear regression analysis data for the calibration plots showed good linear relationship with r² = 0.9998 in the working concentration range of 5–100 μgmL^-1.The LOD and LOQ were 90 and 273 ngmL^-1 respectively. The drug was subjected to stress degradation using acid, alkali, hydrogen peroxide, dry heat, wet heat and uv light. The standard drug peaks were well resolved from the degradation products’ peaks with significantly different retention time (Rt).

HPLC; degradation; stability-indicating; Balofloxacin (BLFX)

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