Development and Validation of Analytical Method for Estimation of Balofloxacin in Bulk and Pharmaceutical Dosage Form by RP-HPLC

Abstract

The objective of the present study is to develop simple, accurate, sensitive and economic method for effective quantitative determination of Balofloxacin in active pharmaceutical ingredient. as well as in Pharmaceutical dosage forms by using HPLC. The newly developed method is validated in accordance with the analytical parameters for quantitative estimation of Balofloxacin in pharmaceutical dosage forms as per ICH guidelines. The method was validated for parameters like accuracy, linearity, precision, specificity, ruggedness, robustness, and system suitability. The detection was carried out using UV detector at 249 nm. The solutions were injected at a constant flow rate of 1 ml/min. the linearity range of Balofloxacin was found to be 10-60 g/ml. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Balofloxacin. LOD were found to be 0.210 µg/ml and LOQ found to be 0.637µg/ml for Balofloxacin. The results obtained on the validation parameters met ICH guidelines; it inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.

RP HPLC-Based Method Development, Validation and Stability Indicating Assay of Levosulpiride in Bulk Drug Using Analytical Quality by Design Approach

“…System suitability parameters pass for Tailing which is less than 2.0, acceptable peak area, Rt, plate count was found to be more than 2500, % RSD was found to be less than 2%. The number of USP plate count was found to be 9247, USP tailing factor 1.73, % RSD was found to be 0.2% and retention time was found to be 2.014 mins (10) .…”