A validated RP-HPLC method for quantitative determination of related impurities of cholic acid bulk drugs

• Autorzy: Sheng Z. , Ye R. , Ge S. , Wang C. , Xu X. , Zhang G. , Luo P.

Identyfikatory

DOI

10.1556/1326.2017.00250

• Języki publikacji: EN

Abstrakty

EN

An efficient and convenient reversed-phase high-performance liquid chromatography method has been developed and validated for the quantitative determination of cholic acid bulk drugs and their related impurities. Chromatographic separation was performed on a YMC-Pack ODS-AQ column (250 mm × 4.6 mm, S-5 μm, 12 nm), and the mobile phase consisted of acetonitrile, methanol, and diluted formic acid solution (pH 2.5) at a flow rate of 1.0 mL/min. The analytes were monitored using a refractive index detector at 30 °C, and the column temperature was 30 °C. Under the above chromatographic conditions, the method has good specificity and specified impurities can be effectively separated. The proposed method is found to have linearity in the 2.0–80.0 μg/mL concentration range with correlation coefficients of not less than 0.9999. The compounds analyzed in the solutions are stable for at least 7 days, and spike recoveries for all specified impurities range from 91.3% to 109.3% with relative standard deviations (RSDs) not more than 7.3%. The limit of detection and the limit of quantification for the analytes are 0.060 μg/mL and 2.0 μg/mL, respectively. The proposed method can be applied in the quality control assay of cholic acid bulk drugs, with the advantages of simplicity, accuracy, robustness, good selectivity, and high sensitivity.

Słowa kluczowe

EN

Reversed-phase HPLC; quality control; bulk drugs; cholic acids

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2018
• Tom: Vol. 30, no. 2
• Strony: 114--118
• Opis fizyczny: Bibliogr. 15 poz., rys., tab.

Twórcy

autor

Sheng Z.

• School of Chemical and Environmental Engineering, Wuyi University, Jiangmen 529020, China

autor

Ye R.

• School of Chemical and Environmental Engineering, Wuyi University, Jiangmen 529020, China
• New Fortune Environmental Protection Co. Ltd. Yamen Jiangmen, Jiangmen 529152, China

autor

Ge S.

• School of Chemical and Environmental Engineering, Wuyi University, Jiangmen 529020, China

autor

Wang C.

• New Fortune Environmental Protection Co. Ltd. Yamen Jiangmen, Jiangmen 529152, China

autor

Xu X.

• School of Chemical and Environmental Engineering, Wuyi University, Jiangmen 529020, China

autor

Zhang G.

• New Fortune Environmental Protection Co. Ltd. Yamen Jiangmen, Jiangmen 529152, China

autor

Luo P.

• New Fortune Environmental Protection Co. Ltd. Yamen Jiangmen, Jiangmen 529152, China

Bibliografia

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• [12] European Directorate for Quality Medicines, European Pharmacopoeia 7.0, 3180–3181.
• [13] ICH Harmonised Tripartite Guideline Q2 (R1), Validation of Analytical Procedures: Text and Methodology. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed Dec. 2016).
• [14] Center for Drug Evaluation of China Food and Drug Administration , Technical Guideline for Analytical Method Validation on Chemical Drug Quality Control, http://www.cde.org.cn/zdyz.do?method=largePage&id=2063 (accessed Dec. 2016).
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Uwagi

PL

Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).