title: Development and Validation of Different Ultraviolet-Spectrophotometric Methods for the Estimation of Besifloxacin in Different Simulated Body Fluids.
abstract: In the present study a simple, accurate, precise, economical and specific UV-spectrophotometric method for estimation of besifloxacin in bulk and in different pharmaceutical formulation has been developed. The drug shows maximum λmax289 nm in distilled water, simulated tears and phosphate buffer saline. The linearity range of developed methods were in the range of 3-30 μg/ml of drug with a correlation coefficient (r(2)) 0.9992, 0.9989 and 0.9984 with respect to distilled water, simulated tears and phosphate buffer saline, respectively. Reproducibility by repeating methods as %RSD were found to be less than 2%. The limit of detection in different media was found to be 0.62, 0.72 and 0.88 μg/ml, respectively. The limit of quantification was found to be 1.88, 2.10, 2.60 μg/ml, respectively. The proposed method was validated statically according to International Conference on Harmonization guidelines with respect to specificity, linearity, range, accuracy, precision and robustness. The proposed methods of validation were found to be accurate and highly specific for the estimation of besifloxacin in different pharmaceutical formulations.
authors.affiliation: R. V. Northland Institute, Chithera, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: C L
authors.initials: CL
authors.lastname: Singh
authors.affiliation: R. V. Northland Institute, Chithera, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: A
authors.initials: A
authors.lastname: Singh
authors.affiliation: R. V. Northland Institute, Chithera, Dadri, Gautam Budh Nagar-203 207, India.
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.affiliation: KPS, Clinical Services, Greater Noida, Gautam Budh Nagar-201 306, India.
authors.forename: M
authors.initials: M
authors.lastname: Kumar
authors.affiliation: Galgotias University, Yamuna Expressway, Greater Noida, Gautam Budh Nagar-201 306, India.
authors.forename: P K
authors.initials: PK
authors.lastname: Sharma
authors.affiliation: Delhi Institute of Pharmaceutical Sciences and Research, Pushp Vihar-III, New Delhi-110 017, India.
authors.forename: D K
authors.initials: DK
authors.lastname: Majumdar
keywords: Besifloxacin; ICH guidelines; Simulated tears; UV-Spectrophotometric method; Validation