A reversed-phase high-performance liquid chromatographic assay for the determination of N-acetylcysteine in aqueous formulations |
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Authors: | Farquhar J Finlay G Ford P A Martin-Smith M |
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Affiliation: | Glaxo Group Research Ltd, Ware, Hertfordshire, SG12 ODJ, UK. |
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Abstract: | A stability-indicating assay is described for the determination of N-acetylcysteine in aqueous pharmaceutical formulations. The sample is diluted to an appropriate concentration with dilute aqueous orthophosphoric acid. An aliquot of the solution, containing added l-tyrosine as an internal standard, is chromatographed using a 10-mum C(18) stationary phase with dilute orthophosphoric acid (pH 2.0) containing 0.5% w/v of sodium perchlorate as the mobile phase. The assay, which has a relative standard deviation of about 0.8%, can also be used as a test for related impurities in N-acetylcysteine. It is also suitable for determining the N-acetylcysteine content of the drug substance. |
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Keywords: | reversed-phase high-performance liquid chromatography degradation studies impurities. |
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