Quantitative determination of N-Acetyl cysteine by RP-HPLC method in bulk and parenteral injection
Asian Journal of Pharmacy and Pharmacology
Objective: The aim of the present work was to develop a simple and specific RP-HPLC method for the estimation of Nacetyl cysteine (NAC) in bulk and parenteral dosage form. Separation was carried out on a Materials and methods: C18 Phenomenex column (250 mm × 4.6 mm i.d., 5 with an isocratic mobile phase constituting of μm particle size) potassium dihydrogen phosphate with pH 3.0: Acetonitrile (95:5 v/v). The flow rate was kept at 1.0 mL/min with a total run time of 10 minutes. A UV-detector was
... . A UV-detector was employed for the detection of NAC at a wavelength of 213 nm. The developed method was validated as per ICH guidelines for various validation parameters. Results and Discussion: NAC showed a retention time of 4.205 min. A calibration curve was constructed in the range of 10-50 g/ml with a μ correlation coefficient R = 0.9999. Specificity was demonstrated by the absence of interference peaks of the excipients 2 in the parenteral dosage form. The accuracy was demonstrated as mean % recovery and it was found to be 101.6 %. The assay of the commercial parenteral injection was found to be 101.69%. The method was also evaluated for robustness and ruggedness and the results obtained were satisfactory. It is concluded that the developed RP-HPLC Conclusion: method was specific, precise, accurate, sensitive and robust for the estimation of NAC in bulk and parenteral dosage forms.