Development and validation of stability-indicating RP-HPLC method for the determination of Levocabastine HCl in bulk drug and in ophthalmic suspensions

Abstract

A new stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of Levocabastine HCl in bulk drugs and in ophthalmic suspensions in the presence of degradation products generated from forced degradation studies. The system consisted of Thermo Hypersil CPS column (CN column) (150 mm, 4.6 mm i.d., 5 μm), and the detection was performed at 210 nm. The mobile phase was a mixture of ethanol–ammonium acetate (pH 3.0; 0.05 M) (40:60, v/v) pumped at 25 °C with a flow rate of 1.2 mL/min. The calibration curve was linear from 50 to 200 μg/mL with R2 > 0.999. The detection limit (DL) and quantitation limit (QL) were 0.9 and 3 μg/mL, respectively. Accuracy (mean recovery: 100.11%) and precision were found to be satisfactory. Stress conditions including acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat were applied. The degradation products did not interfere with the detection of Levocabastine HCl, thus the method can be considered as a stability indicating method. The proposed method can be used for quality control assay of Levocabastine HCl in bulk drug and in ophthalmic suspensions and for the stability studies as a result of the ability of the method to separate Levocabastine HCl from its degradation products and excipients.

Keywords

• Levocabastine HCl
• RP-HPLC method
• Ophthalmic suspensions
• Validation
• Stability-indicating method