Development and validation of a new RP-HPLC method for simultaneous estimation of N-acetylcysteine and L-arginine in combined dosage form

Abstract

An isocratic, reversed phase-liquid chromatographic method was developed for quantitative determination of N-acetylcysteine and L-Arginine in combined dosage form. A Waters Xterra Rp8, (150∗4.6∗5μm) column with a mobile phase containing a Phosphate Buffer (pH 4.5) and Methanol (90: 10 v/v) was used. The flow rate was maintained at 0.8 ml/min, column temperature at 30°C and effluents were monitored at 248 nm. The retention times of N-acetylcysteine and L-Arginine were found to be 2.697 min and 3.156 min, respectively. The correlation co-efficient for N-acetylcysteine and L-Arginine was found to be 0.99 and 0.99, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of N-acetylcysteine and L-Arginine in formulations was found to be in the range of 97-103% and 97-103% respectively confirms the non-interferences of the excipients in formulation. Due to its simplicity, rapidness and high precision, this method can be successfully applied for estimation of N-acetylcysteine and L-Arginine in combined pharmaceutical dosage forms.