Development and Validation of a High Performance Liquid Chromatographic Method for Determination of Bimatoprost in Chitosan-Based Ocular Inserts

• Published in: Analytical letters Vol. 48; no. 3; pp. 531 - 540
• Main Authors: Franca, Juçara R., Batista, Luciana D., Ribeiro, Tatiana G., Fernandes, Christian, Castilho, Rachel O., Faraco, André A. G.
• Format: Journal Article
• Language: English
• Published: Taylor & Francis Group 11-02-2015
• Subjects: Bimatoprost; Blindness; Chitosan; Controlled release; Drug delivery systems; High-performance liquid chromatography; Inserts; Liquid chromatography; Medical services; Pharmaceuticals; Ultraviolet; Ultraviolet detection
• ISSN: 0003-2719; 1532-236X
• DOI: 10.1080/00032719.2014.947533

Glaucoma is one of the most prominent causes of blindness around the world. Conventional eye-drops, currently used in the treatment of the disease, must be taken every day and can cause severe systemic side effects. In order to address these problems, a solvent casting method was used to produce chitosan-based polymeric ocular inserts for controlled release of bimatoprost, a prostaglandin analog highly powerful in reducing intraocular pressure. The development and validation of quality control methods are an important concern in the field of pharmaceutical technology when dealing with new drug delivery systems. In this context, a rapid method using reverse phase high-performance liquid chromatography with ultraviolet detection was developed and validated for the determination of the pharmaceutical into the chitosan-based polymeric matrix. The method was linear (determination coefficient higher than 0.99) over the range of 3.00-15.00 µg/mL, precise (relative standard deviation lower than 5%), accurate (recovery of 104.09%), selective, and had limits of quantification and detection of 0.90 and 0.60 µg/mL, respectively. The validated method was successfully employed for assay and performance measurements of bimatoprost in the developed formulation.