[논문]Validations of Analysis Methods for Decursin and Decursinol Angelate of Angelicae gigantis Radix by Reversed-Phase Liquid Chromatography

Lee, Jong-Pill; Chang, Seung-Yeup; Park, Sang-Yong

Validations of Analysis Methods for Decursin and Decursinol Angelate of Angelicae gigantis Radix by Reversed-Phase Liquid Chromatography 원문보기

Natural product sciences, v.10 no.6, 2004년, pp.262 - 267

Lee, Jong-Pill (Department of Natural Medicines Evaluation, KFDA) , Chang, Seung-Yeup (Department of Natural Medicines Evaluation, KFDA) , Park, Sang-Yong (College of Pharmacy, Kyung Hee University)

Abstract ▼ AI-Helper

A reversed-phase liquid chromatographic method for decursin and decursinol angelate of Angelicae gigantis Radix, an important crude drug in Korean traditional medicine, was developed and validated. Decursin and decursinol angelate, the structure isomer (pyranocoumarin) each other, are the main organic constituents in Angelicae gigantis Radix. This method was developed using a RP-18 column, UV detector at 280 nm and 50% acetonitrile solution containing 0.01 M sodium dodecyl sulfate and 25 mM sodium dihydrogen phosphate (pH 5.0) as the mobile phase. Various validation parameters were included and evaluated satisfactorily. Linearity was established in range 2-75 mg/ml of decursin and decursinol angelate (correlation coefficient = 0.9997 and 0.9995, respectively). This analytical method showed good accuracy (98.1% and 99.5%, respectively). Precision (repeatability) revealed a relative standard deviation value of 1.71% (decursin) and 3.19% (decursinol angelate). For intermediate precision measure the considered variables were equipment and days. A robustness test showing the influence of deferent counter-ion concentration in mobile phase was also performed.

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제안 방법

, 2002; Toker et _,L, 2001). A reversedphase HPLC method was thus developed and then validated for the qantitative assay of decursin and decursinol angelate in the crude drug as a new, simple and rapid method.
1548 g/mg by the same HPLC condition. The samples for accuracy test were prepared by mixing the standard soltions of decursin and decursinol angelate into the sample of crude drug. The accuracy results, expressed as recovery and relative standard deviation (RSD), were summarized in Tables 1 and 2.

대상 데이터

Louis, MO, USA). Lichrosolc acetonitrile was purchased from Merk (Darmstadt, Germany). Water used for the mobile phase was deionized, distilled and filtered through a 0.

이론/모형

The standards of decursin and decursinol angelate were provided by Professor Young-Choong Kim in Seoul National University (Seoul, Korea). Sodium dihydrogen phospate dihydrate and phosphoric acid were purchased from Wako Pre Chemical (Osaka, Japan) and sodium dodecyl sulfate was from Sigma (St.

성능/효과

Results of robustness test showed that the method was susceptible mainly to change of column brand (manufa cturer) and acetonitrile percentage in mobile phase. Whenever this analytical method is applied, these factors should be selected carefully.
Whenever this analytical method is applied, these factors should be selected carefully. Study of validation parameters according to ICH recommendation was demonstrated that the method is specific linear, accurate and precision within the established range. When linearity of peak area was tested in the range 2-75 mg/ml of decursin and decursinol angelate, their correlation coefficient were were between 96.
Study of validation parameters according to ICH recommendation was demonstrated that the method is specific linear, accurate and precision within the established range. When linearity of peak area was tested in the range 2-75 mg/ml of decursin and decursinol angelate, their correlation coefficient were were between 96.08 and 102.44%, showing 1.44% (decursin) and 2.09%(decursinol angelate) of RSD value. Precision (repeatability) revealed a relative standard deviation value of 1.

참고문헌 (10)

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