Simultaneous Estimation of Netarsudil and Latanoprost by Stability Indicating RP-HPLC-Pda in Pure Binary Blend and their Ophthalmic Solution

Abstract

>A trouble-free, easy, specific, and extremely sensitive HPLC method was established for concurrent estimation of netarsudil and latanoprost in pure bulk and their combined ophthalmic solution. A good separation was achieved by using kromosil C18 (250 x 4.6 mm, 5μ,100 Ao) column, a mobile portion of Acetonitrile: buffer (0.1N KH2PO4) (50:50 v/v) with isocratic elution, a flow rate of 1-mL/min and detection wavelength of 220 nm. The drug substance was exposed to an intense stress environment like hydrolysis with acid and base, peroxide oxidation, and thermal degradation as per ICH provisions to evaluate the stability of the analytes. The netarsudil and latanoprost were eluted at 2.53 and 3.51 mintues, respectively. The anticipated method shows the linear response from 2.5 to 15 ppm and 0.625 to 3.75 ppm for netarsudil and latanoprost, respectively. The limit of detection (LoD), limit of quantitation (LoQ) were calculated as 0.023 and 0.07 ppm for netarsudil, 0.007 ppm, and 0.022 ppm latanoprost, respectively. The degradants formed by forced degradation studies were well resolved from netarsudil and latanoprost peaks. The method was extremely sensitive, accurate, economical, and stability indicating. Hence, the method has a high capacity to be used in the pharmaceutical industry for analysis of netarsudil and latanoprost in the quality control department.