Development, Validation and Application of a Novel UHPLC-UV Method for the Simultaneous Determination of Valsartan and Nifedipine in the New Formulation of Self-Nanoemulsifying Drug Delivery Systems

Abstract

Our objective is to develop a robust method to quantify valsartan (VAL) and nifedipine (NIF) in developed a self-nanoemulsifying drug delivery formulation. An in-house ultra-high-performance liquid chromatography (UHPLC UV) method has been developed and validated for the simultaneous determination of VAL and NIF. The UV detection was performed isocratically, with a mobile phase comprised of acetonitrile, methanol and ammonium formate in the ratios of (15:45:40% v/v) and a flow rate of 0.35 mL/min at 236 nm. The correlation coefficients (R2) of this linear regression were 0.9984 for NIF and 0.9997 for VAL, respectively. The limit of detection (LOD) for NIF as 3.78 ppm, whereas the limit of detection (LOD) for VAL was 1.56 ppm. The limit of quantification (LOQ) of NIF and VAL were 11.47 ppm and 4.73 ppm, respectively. This method was effectively utilized to determine the amount of drug entrapped and drug loading efficiency percentage of the NIF and VAL self-nanoemulsifying formulations.