書誌事項
- タイトル別名
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- Determination of Magnesium Stearate in Pharmaceutical Preparations Using Derivatization with 2-Nitrophenylhydrazine and HPLC
- ユウドウタイカ HPLCホウ ニ ヨル セイザイ チュウ ステアリンサン マグネシウム ノ ジンソク ブンリ テイリョウホウ ノ カクリツ
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抄録
In general, spectrophotometric methods (inductively coupled plasma or atomic absorption spectrophotometry) are used for the assay of magnesium stearate (Mg-St). In this study, a new rapid, selective assay method was developed for Mg-St in pharmaceutical formulations. The method was based on isocratic reverse-phase liquid chromatography using a mobile phase of acetonitrile-water (80:20, v/v) after precolumn derivatization with 2-nitrophenyl hydrazine for sensitive UV detection. Margaric acid was used as an internal standard and the substances were detectable at 230 nm or 400 nm. Using a short (2 cm) HPLC column reduced the analytical time to 5 min. Validation of the newly developed method was performed in accordance with the International Conference on Harmonization guidelines. The linearity range for Mg-St was 0.00—0.04 mg/ml (as the concentration of injected sample solution) and their correlation factor was 0.9998. The determination and detection limits for Mg-St were 6 μg and 2 μg, respectively. The proposed method was successfully applied to the determination of trace amounts of Mg-St in commercially available tablets with a high recovery percentage, good accuracy, and precision.<br>
収録刊行物
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- 薬学雑誌
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薬学雑誌 125 (3), 299-305, 2005-03-01
公益社団法人 日本薬学会
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詳細情報 詳細情報について
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- CRID
- 1390001206127934592
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- NII論文ID
- 110003667408
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- NII書誌ID
- AN00284903
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- ISSN
- 13475231
- 00316903
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- NDL書誌ID
- 7275444
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- PubMed
- 15738629
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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- 抄録ライセンスフラグ
- 使用不可