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

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

Acta Chromatographica

2018

Vol. 30, no. 2

114--118

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.

Determination of cholic acid in bile and pharmaceutical preparation

Kurzawa M., Koter I., Szłyk E.

Chemia Analityczna

2006

Vol. 51, No. 3

411-418

New analytical procedures for determination of cholic acid in powdered and liquid bile samples and in Tympachol, pharmaceutical preparation derived from bile have been developed. Spectrophotometric methods are based on the reaction between cholic acid and aldehydes (5-methyl furfural, 5-methyl-2-tiophene and ortophtalic) in sulfuric acid solution. Molar absorptivity coefficients for the obtained species ranged from 1.38 x 104 to 6.94 x l04 L mol-1 L mol-1and correlation coefficient exceeded 0.9984. The RSD values for the developed procedures were not higher than 2.85% for the powdered bile sample. 3.31% for the liquid bile sample, and 3.48% for Tympachol. Accuracy and precision were investigated applying the Student-t and F-Snedecor tests and the results were compared to those obtained by Polish Standard and HPLC methods.

W pracy opisano nowe analityczne procedury do oznaczania kwasu cholowego w żółci sproszkowanej, piynnej oraz w Tympacholu - preparacie farmaceutycznym na bazie żółci. Metody spektro foto metryczne zostały oparte na reakcji pomiędzy kwasem cholowym a aldehydami: 5-metylofurfuraIem, 5-metylo-2-liofenowym oraz ortoftalowym w środowisku kwasu siarkowego. Molowe współczynniki absorpcji dla otrzymanych związków wynosiły od 1,38 x 104 do 6,94 x 104 L mol-1 L mol-1, a współczynniki korelacji przekraczały 0,9984. Wartości RSD dla wszystkich opracowanych procedur w przypadku żółci sproszkowanej były niższe niż 2,85%, w przypadku żółci płynnej niższe niż 3,31%, natomiast w przypadku preparatu nie przekraczały 3,48%. Dokładność i precyzję opracowanych metod porównano z wynikami uzyskanymi metodą opisaną w Polskich Normach oraz z wynikami uzyskanymi metodą HPLC, stosując tesly t-Studenta i F-Snedecora.