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KMID : 0614020040190010020
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Journal of Pharmaceutical Sciences (C.N.U.)
2004 Volume.19 No. 1 p.20 ~ p.24
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Analysis of Related Compounds from Salbutamol Raw Material and Preparations by High-Performance Liquid Chromatography
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Nguyen Thanh-Dong
Kamg Ji-Youn
Kang Jong-Seong
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Abstract
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Salbutamol and related compounds found in raw material and commercial salbutamol products were analyzed by high-performance liquid chromatography. The related compounds and some unknown impurities in the test solution were separated on the LiChrosorb RP-Cl8 column with the mobile phase of phosphate buffer (2.5 g/ℓ, pH 3.65) including sodium heptanesulfonate (2.87 g/ℓ) - acetonitrile (78 : 22) at the flow rate of 1 ㎖ /min and detected at UV 220 nm. Salbutamol related compounds A, B, C, E, G and H were identified by the relative retention time of the related compounds D and F with salbutamol. The within-day precisions of the separated compounds were less than 3.8%, excluded the unimportant related compounds and impurities. The related compounds in four commercial salbutamol products exceeded the limit in the European Pharmacopoeia. The patten of the related compounds in the salbutamol raw materials and products provided that the salbutamol could be categorized in three different groups, indicating that the materials originated from different source or treated in different way.
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KEYWORD
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Salbutamol, related compounds, impurities, high-performance liquid chromatography
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