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.

Development of loteprednol etabonate-loaded cationic nanoemulsified in-situ ophthalmic gel for sustained delivery and enhanced ocular bioavailability

“…The supernatant was separated and filtered using a 0.22 mm membrane filter. The concentration of LE was analyzed by the reported HPLC method (Han & Segall, 2014).…”

“…HPLC analysis of LE in rabbit aqueous humor A previously described HPLC method for the determination of LE in eye drops was implemented to find out the LE pharmacokinetics in the rabbit aqueous humor (Han & Segall, 2014). The LC method was carried out on a Shimadzu Coporation, LC-20AD, Tokyo, Japan 4.6 Â 250 mm column (USA) (Inertsil ODS-3 reverse-phase C18 column) preserved at room temperature.…”

Development of Solid Lipid Nanoparticles and Nanostructured Lipid Carriers of Loteprednol Etabonate: Physicochemical Characterization and Ex Vivo Permeation Studies

“…The quantity of LE was measured by using an HPLC method. For this goal, a previously published analytical method was developed with slight modi cations, then validated (20). Brie y, an HPLC instrument (Agilent 1110, USA) equipped with a diode array detector (Agilent Tech, USA) was chosen.…”

“…04.03-SP2-105) to control the components of the instrument, to obtain and keep the virtual datum. The ICH Q2 (R1) guideline were followed for the method validation studies (20).…”

“…The clear supernatant was isolated and ltered (0.22 µm lter was used). The concentration of LE was determined by using a high performance liquid chromatography (HPLC) method (20).…”