title: A validated specific stability-indicating RP-HPLC assay method for the determination of loteprednol etabonate in eye drops.
abstract: A new stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of loteprednol etabonate in bulk drugs and in ophthalmic suspensions in the presence of degradation products generated from forced degradation studies. The system consisted of Agilent Technologies Zorbax Eclipse XDB-Phenyl 5 µm 4.6 × 250 mm, and detection was performed at 244 nm. The mobile phase consisted of water-acetonitrile-acetic acid (34.5:65.0:0.5, v/v/v) run at a flow rate of 1 mL/min and maintained at room temperature. The calibration curve was linear from 30 to 70 µg/mL with r > 0.999. Accuracy (mean recovery 100.78%) and precision were found to be satisfactory. Stress conditions including acid and alkali hydrolysis, water stress, oxidation, photolysis and heat were applied. The degradation products did not interfere with the detection of loteprednol etabonate, thus the method can be considered as a stability-indicating method. The proposed method can be used for quality control assay of loteprednol etabonate in bulk drug and in ophthalmic suspensions and for stability studies as a result of the ability of the method to separate loteprednol etabonate from its degradation products and excipients.
authors.affiliation: Cátedra de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, CONICET, Junín 956, Buenos Aires 1113, Argentina.
authors.forename: Yong K
authors.initials: YK
authors.lastname: Han
authors.affiliation: Cátedra de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, CONICET, Junín 956, Buenos Aires 1113, Argentina asegall@ffyb.uba.ar.
authors.forename: Adriana I
authors.initials: AI
authors.lastname: Segall
mesh_terms: D000730:Androstadienes / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods; D004355:Drug Stability; D000069559:Loteprednol Etabonate; D009883:Ophthalmic Solutions / Q000737:chemistry*; D011786:Quality Control
chemical_list: D000730:Androstadienes; D009883:Ophthalmic Solutions; D000069559:Loteprednol Etabonate