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Monitoring of preservatives in herbal liquid preparations

액상한약제제의 보존제 모니터링

  • Received : 2011.02.07
  • Accepted : 2011.03.02
  • Published : 2011.04.25

Abstract

Quantitative HPLC analysis for the determination of in herbal liquid preparations was improved from the general test method besides the Korean Pharmacopeia. Good chromatographic separation of samples containing parabens, interferences, and other pharmaceutical excipients was effectively achieved by using acetonitrile water (containing 1% glacial acetic acid) mixture (30:70 v/v) as mobile phase. To monitor preservatives (benzoic acid, parabens, sorbic acid, dehydroacetic acid, and their salts) in herbal liquid preparations, a group of 47 samples was divided into two different group: preservative labeled group and unlabeled group. From the results, the contents of preservatives in 31 samples of preservative labeled group fell under KFDA regulations, and the contents of dehydroacetic acid in 6 samples of preservative labeled group were not followed by KFDA regulations. Preservatives were detected in 3 samples out of 10 samples in preservative unlabeled group.

Keywords

herbal liquid preparations;pharmaceutical excipients;preservatives

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