title: A single reversed-phase UPLC method for quantification of levofloxacin in aqueous humour and pharmaceutical dosage forms.
abstract: An attempt was made to develop a single, rapid, specific, and sensitive gradient reversed-phase ultra-performance liquid chromatographic method for quantitative analysis of levofloxacin. The single method thus developed is applied for the quantification of levofloxacin both in aqueous humour as well as pharmaceutical dosage forms (i.e., tablets and eye drops). The newly developed method is applicable for pharmacokinetic studies of eye formulations. The chromatographic separation of levofloxacin was achieved on a Waters Acquity HSS T-3 column (100 x 2.1 mm, 1.8 microm) within a short run-time of 5 min. The method was validated according to the ICH guidelines with respect to system suitability, linearity, limit of quantitation and detection, precision, accuracy, robustness, and specificity. Forced degradation studies were also performed in levofloxacin bulk drug samples to demonstrate the stability-indicating power of the developed ultra-performance liquid chromatography method. The developed method was then successfully applied for the ocular pharmacokinetic study of levofloxacin eye formulations and assay of levofloxacin pharmaceutical dosage form.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard (Hamdard University), New Delhi-110062, India. himanshu18in@yahoo.com
authors.forename: Himanshu
authors.initials: H
authors.lastname: Gupta
authors.forename: M
authors.initials: M
authors.lastname: Aqil
authors.forename: R K
authors.initials: RK
authors.lastname: Khar
authors.forename: Asgar
authors.initials: A
authors.lastname: Ali
authors.forename: Prakash
authors.initials: P
authors.lastname: Chander
mesh_terms: D000818:Animals; D001082:Aqueous Humor / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase; D064704:Levofloxacin; D016014:Linear Models; D015242:Ofloxacin / Q000032:analysis* / Q000737:chemistry; D009883:Ophthalmic Solutions / Q000737:chemistry; D011817:Rabbits; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013607:Tablets / Q000737:chemistry; D013997:Time Factors
chemical_list: D009883:Ophthalmic Solutions; D013607:Tablets; D064704:Levofloxacin; D015242:Ofloxacin