Journal article Open Access

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND N-ACETYLCYSTINE IN ITS BULK AND EFFERVESCENT TABLET DOSAGE FORM

D. Derle, S. Amrutkar*, S. Kulkarni, N. Derle

The present study describes a simple, accurate, precise and cost effective Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for simultaneous estimation of Paracetamol and N-Acetylcysteine in its bulk and effervescent tablet dosage formulation. The approach of research was to develop an effective RP-HPLC method since there were only few voltammetric methods which were voltammetric in nature. The developed method involved mobile phase containing Water: Acetonitrile in the proportion of 97:3 %V/V, at a flow rate of 1.0 ml/min and oven temperature of 30° C. The analyte were resolved by using isocratic programme on HPLC system containing UV- visible detector with Shimadzu class VP Software and Inertsile C18 (250 mm × 4.6 mm i.d.) 5 μm column. The detection of N-Acetylcysteine and Paracetamol were carried out at 220 nm and the method was validated High linearity of the developed method was confirmed over concentration range of 40-80 μg/ml for Paracetamol and 40-80 μg/ml for N-Acetylcysteine with correlation coefficient of 0.999 and 0.999 respectively at selected wavelength. The percentage RSD for Precision and Accuracy of the method was found to be less than 2%. Peaks were obtained at Retention times of 14.6 & 5.3 min for Paracetamol & N-Acetylcysteine respectively. The major outcomes of the result were that the method showed good reproducibility and it is accurate, precise, specific and sensitive. It can be concluded that the proposed method can be successfully used for the estimation of Paracetamol and N-Acetylcysteine in combination dosage formulations.

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