SIMPLE COST EFFECTIVE STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF BESIFLOXACIN
Mohd Faizan, Rajesh Gour, Akhlesh Kumar Singhai
ABSTRACT
A simple, rapid, accurate, precise, cost-effective, and stability-indicating RP-HPLC method was developed and validated for the estimation of Besifloxacin in pharmaceutical dosage form. Chromatographic separation was achieved using a mobile phase consisting of 10 mM potassium dihydrogen phosphate and methanol in the ratio of 20:80 v/v at a flow rate of 1.0 ml/min. Detection was carried out at 247 nm using a UV detector. The developed method showed good linearity in the concentration range of 5–25 µg/ml with a correlation coefficient (r²) of 0.999. The method was validated according to ICH guidelines for parameters such as linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantification (LOQ). The percentage recovery values were found to be within acceptable limits, indicating good accuracy of the method. Precision studies demonstrated low %RSD values, confirming the reproducibility of the developed method. The LOD and LOQ values were found to be 0.65 µg/ml and 1.85 µg/ml, respectively, indicating adequate sensitivity. Forced degradation studies under acidic, alkaline, oxidative, and photolytic conditions confirmed the stability-indicating capability of the developed method. The proposed RP-HPLC method was found to be simple, reliable, economical, and suitable for routine quantitative analysis of besifloxacin in pharmaceutical formulations.
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