Sreenivasa Charan Archakam1*, Sridhar Chenchugari2, Chandrasekhar Kothapalli Banoth3
1Research Scholar, Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University Anantapur, Anantapuramu -515002, Andhra Pradesh, India.
2Department of Pharmaceutical Analysis, Sri Padmavathi School of Pharmacy, Tiruchanoor, Tirupati – 517503, Andhra Pradesh, India.
3Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Anantapuramu -515002, Andhra Pradesh, India.
*Address for Corresponding Author
Sreenivasa Charan Archakam,
Department of Pharmaceutical Sciences,
Jawaharlal Nehru Technological University Anantapur (JNTUA), Anantapuramu-515002, Andhra Pradesh, India.
Objective: The aim of the present work was to develop a simple and specific RP-HPLC method for the estimation of N-acetyl cysteine (NAC) in bulk and parenteral dosage form. Materials and methods: Separation was carried out on a C18 Phenomenex column (250 mm × 4.6 mm i.d., 5 μm particle size) with an isocratic mobile phase constituting of 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 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 μg/ml with a correlation coefficient R2 = 0.9999. Specificity was demonstrated by the absence of interference peaks of the excipients 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. Conclusion: It is concluded that the developed RP-HPLC method was specific, precise, accurate, sensitive and robust for the estimation of NAC in bulk and parenteral dosage forms.
Keywords: N-Acetylcysteine, RP-HPLC, validation, quantitative determination, parenteral