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Published on:July 2017
Indian Journal of Pharmaceutical Education and Research, 2017; 51(4):626-635
Original Article | doi:10.5530/ijper.51.4.93

Development and Validation of an Analytical Method for Related Substances in N-acetyl–L-cysteine Effervescent Tablets by RP-HPLC


Authors and affiliation (s):

Elizabeth Mary Mathew1, Angadi Ravi2, Nalawade Rameshwar2, Moorkoth Sudheer1, Bhat Krishnamurthy1

1Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka -576104, INDIA.

2STEER Life India Pvt. Ltd, Peenya Industrial Area, Bengaluru, Karnataka-560058, INDIA.

Abstract:

Background: The reported chromatographic methods for N-acetyl cysteine [NAC] are reverse phase HPLC and ion pair chromatography [IPC] for related substances test in bulk and in formulations. No reported stability indicating methods for the estimation of related substances in NAC effervescent formulation was found in literature. Objective: The present work was aimed at developing a selective, sensitive and reproducible stability indicating high-performance liquid chromatographic method for the quantitative determination of known, unknown impurities, degradation impurities and processrelated impurities of NAC effervescent formulation. Method: A reversed phase ion pair chromatographic method was developed employing Cadenza C18 column as the stationary phase and 0.01M octane sulphonate [pH 2.20], methanol and acetonitrile in the ratio 90:8:2 as the mobile phase. A gradient programme was followed with a run time of 55 minutes. 0.3 M hydrochloric acid was selected as the optimum diluent. The performance of the method was validated according to the ICHQ2R1 guidelines. Results: The method was found to be linear from 1.5 to 25μg/ml for impurities A, C and D and from 2.0 to 25 μg/ml for impurity B. The official impurities C and D were mapped in all stress conditions. Additionally, impurity B was also seen in acidic conditions. Conclusion: The results from the study demonstrate that the method is suitable for evaluating the stability of NAC effervescent tablet.

Key words: N-acetyl cysteine, Reverse phase HPLC, Effervescent formulation, Ion pair chromatography, Related substances,Validation.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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