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N-Acetylcysteine is an active pharmaceutical agent and nutritional supplement primarily used as a mucolytic agent and in the management of Paracetamol overdose. A simple, specific and precise reverse phase high performance liquid chromatographic (RP HPLC) method for the analysis of Acetylcysteine in wet cough syrup dosage form has been developed and validated. Sample was resolved on a Waters Symmetry, C18 (150mm X 4.6 mm i.d., particle size 3.5μ) column. The gradient system was used with mobile phase consisting of Acetonitrile and 0.05 M phosphate buffer (pH was adjusted to 3.0 + 0.05 by using orthrophosphoric acid), at a flow rate of 0.8 ml/min at ambient temperature. Detection was carried out at 214nm. The retention time of about 4.6 minutes was recorded. Force degradation studies were carried out for acidic, alkaline, oxidative, reductive and photolytic exposure of the drug substance and drug product. The method was found to be specific for Acetylcysteine and was able to resolve the NAC peak from formulation excipients. The calibration curve was linear over the concentration range of 400-600 μg/ml (R=0.999). The proposed method was applicable to routine analysis of Acetylcysteine in wet cough syrup dosage form.
Acetylcysteine, RP-HPLC, Mucolytic Agent, Validation, Force Degradation, Excipients