Fenspiride hydrochloride (FNS) is used in treating chronic inflammatory diseases, most commonly as a liquid oral solution. FNS produces degradation products along with fenspiride N‐oxide (FNO) and 1‐phenylethyl‐4‐hydroxy‐4‐aminomethyl pipe...
http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
https://www.riss.kr/link?id=O120631719
2018년
-
0269-3879
1099-0801
SCI;SCIE;SCOPUS
학술저널
n/a-n/a [※수록면이 p5 이하이면, Review, Columns, Editor's Note, Abstract 등일 경우가 있습니다.]
0
상세조회0
다운로드다국어 초록 (Multilingual Abstract)
Fenspiride hydrochloride (FNS) is used in treating chronic inflammatory diseases, most commonly as a liquid oral solution. FNS produces degradation products along with fenspiride N‐oxide (FNO) and 1‐phenylethyl‐4‐hydroxy‐4‐aminomethyl pipe...
Fenspiride hydrochloride (FNS) is used in treating chronic inflammatory diseases, most commonly as a liquid oral solution. FNS produces degradation products along with fenspiride N‐oxide (FNO) and 1‐phenylethyl‐4‐hydroxy‐4‐aminomethyl piperidine hydrochloride (PHAP). We aimed to develop and validate a chromatographic method in order to identify the main degradation products in the presence of other compounds from a liquid preparation. The method used a dual gradient using two buffer solutions: the first with pH 4.5 (buffer 1, pH 4.5–MeOH 90:10%, v/v) and the second with pH 2.9 (buffer 2, pH 2.9–acetronitrile–methanol, 65:15:10%, v/v/v). As mentioned, there was a modification of the organic mixture, starting with 10% methanol and ending with a mixture of acetonitrile–methanol (15:10%, v/v). The flow‐rate was 1.5 mL/min. According to the elution program, experimental conditions started with 100% solution S1, which decreased to 0% and, simultaneously, solution S2 increased to 100% during the first 10 min and was maintained for a further 5 min. After 15 min, initial conditions were re‐established. The linearity interval was 0.5–2 μg/mL and the minimum correlation coefficient was 0.999. The recovery factor was 100.47–103.17% and the limit of quantification was 0.19–0.332 μg/mL. Intra‐day maximum precision was 4.08% for FNS and 2.65% for PHAP. This double‐gradient mobile phase produced good specificity in relation to the degradation products of FNS and other constituents of the oral liquid formulation. Forced degradation studies revealed other related substances that were confirmed in mass balance analyses. Degradation products were confirmed in acidic, basic and oxidative media.