Abstract |
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N-Acetyl-L-cysteine is an acetylated amino acid with antioxidant and mucolytic properties. Besides its mucolytic antioxidant effect it also has anti-inflammatory effect and as an antidote in paracetamol poisoning. Purpose: Analytical methods are required to characterize drug substances and drug products composition during all phases of pharmaceutical development. Development of methods to achieve the final goal of ensuring the quality of drug substances and drug products must be implemented in conjunction with an understanding of the chemical behavior and physicochemical properties of the drug substance. This determination requires highly sophisticated instruments and methods like HPLC, HPTLC and Spectrophotometer. Hence there was a need for the development of newer, simple, sensitive, rapid, accurate and reproducible analytical methods for the routine estimation of N-acetylcysteine in bulk and pharmaceutical dosage form Methods: In the present work, two simple, sensitive, specific and validated methods (method IA and method IB) have been developed for the quantitative estimation of NAC in bulk and pharmaceutical dosage form. Method IA, NAC gives light brown colour with Ninhydrine in alkaline medium, which showed ?max at 485.2 nm. In Method IB, the drug was reacted with Fehling’s solutions (A&B in equal volume) and ferric chloride, which produce yellow colour chromogen which showed ?max at 537.2 nm. Results: The linearity was found in concentration range of 50-300µg/ml for both method IA and method IB. The correlation coefficient was found to be 0.9990 and 0.9991 for method IA and method IB respectively. The methods were validated as per ICH guidelines. The LOD and LOQ for estimation of NAC were found as 0.0773, 0.2343 for method IA and 0.0667, 0.2021 for method IB respectively. Conclusion: Proposed methods were successfully applied for the quantitative estimation of NAC in marketed formulations. |