Comparative Study of RP–HPLC and UV Spectrophotometric Methods for Assay of Balofloxacin in Pharmaceutical Dosage Forms

Sanjay Pai PN; Ameet Kolwalkar; Anusha Palekar

Volume : V, Issue : II, February - 2016

Comparative Study of RP–HPLC and UV Spectrophotometric Methods for Assay of Balofloxacin in Pharmaceutical Dosage Forms

Sanjay Pai Pn, Ameet Kolwalkar, Anusha Palekar

Abstract :

Two simple, precise, accurate and economical RP–HPLC and UV spectrophotometric methods were developed and validated for the estimation of balofloxacin in the pharmaceutical dosage forms. The chromatographic separation was achieved isocratically on ACCLAIMTM 120 C18 column (5 �m, 4.6×250 mm) and methanol: 0.25 M phosphoric acid 80:20(v/v) as the mobile phase, at a flow rate of 1ml/min using isocratic elution. Detection was carried out at 293 nm. The retention time was found to be 2.7 min. The linearity range was found to be 5–50 �g/ml with r2 value of 0.9999. Accuracy was determined at 3 different levels by recovery studies and showed percent recovery ranging from 96.70–101.04%. UV spectrophotometric method was developed using 0.1 N HCl as the solvent and absorbance was recorded at λmax of 293 nm. Beer�s law was obeyed in the concentration range of 2–14 �g/ml with r2 value of 0.9975. Accuracy was determined by recovery studies and showed percent recovery ranging from 99.92–101.20%. The developed methods can be used in QC laboratory for routine analysis to ensure the identity, purity, and performance of the drug product.