Development of an HPLC method using chemometric approaches for the determination of latanoprostene bunod in pharmaceutical preparations

ATİLA KARACA S., Guvercin B.

JOURNAL OF RESEARCH IN PHARMACY, cilt.30, sa.1, ss.126-133, 2026 (ESCI, Scopus, TRDizin)

Özet

Latanoprostene bunod has recently emerged as a promising ocular antihypertensive agent due to its potent ability to lower intraocular pressure and its favorable safety profile observed in clinical trials. In this study, a new, simple, and selective HPLC method was developed for quantifying latanoprostene bunod in pharmaceutical formulations. A Box-Behnken experimental design was employed to optimize the chromatographic parameters, including flow rate, organic solvent, and acid content in the mobile phase. The analysis was performed on a C18 column (4.6 x 50 mm, 3.5 mu m), with a mobile phase consisting of water and acetonitrile, both containing 0.01% formic acid (45:55, v/v). Chromatographic conditions were set at a flow rate of 0.6 mL/min, a column temperature of 40 degrees C, and detection at 260 nm. Method validation, following the ICH Q2(R1) guideline, demonstrated excellent linearity over the concentration range of 0.50-20.00 mu g/mL, with LOD and LOQ values of 0.052 mu g/mL and 0.157 mu g/mL, respectively. Precision and accuracy were confirmed with recovery rates between 100-102% and RSD values below 3%, respectively. The validated method was then successfully applied to the analysis of latanoprostene bunod in a commercially available ophthalmic formulation, confirming its suitability for routine quality control use.