Development and validation of a stability-indicating reverse-phase ultra-performance liquid chromatography method for the simultaneous determination of netarsudil and latanoprost in bulk and pharmaceutical formulation

Abstract

Objective: A new sensitive and simple stability-indicating reverse-phase ultra-performance liquid chromatography (RP-UPLC) method for the simultaneous estimation of netarsudil (NT) and latanoprost (LT) in bulk and pharmaceutical formulation. Materials and Methods: Chromatographic separation was achieved through BEH C18 column (50 mm × 2.8 mm i.d × 1.8 μm particle size) using water: methanol (70:30 v/v) mixture used as the mobile phase. The water ACQUITY Model UPLC system with TUV detector and EMPOWER version 2.0 software was monitored at detection wave length 220 nm on isocratic mode with flow rate 0.3 ml/min and the method was validated as per ICH guidelines. Results and Discussion: By applying the proposed method, the retention times of NT and LT were found to be 1.448 and 1.868 min, respectively, and the peak shapes were good. The resolution was found to be 3.8, which indicate good separation between the drug peaks. Quantitative linearity was obeyed in the concentration range of 2.5–15 μg/mL for NT and 0.625–3.75 μg/ml for latanoprost. The proposed stability-indicating RP-UPLC method has been developed and validated and found to be simple, specific, accurate, precise, and less time consuming. Conclusion: This method was successfully applied for the determination of NT and LT in their pharmaceutical formulation and hence can be used for the routine analysis of these drugs in combined dosage form.