Determination of fenoverine, a modulator of smooth muscle motility, in capsules and in human plasma: Application to dosage form stability and a pilot study in humans

Oliver Yoa‐Pu Hu, Pu‐Hsiang ‐H Chen, Yaw‐Ju ‐J Fang, Hung‐Shang ‐S Tang, Li‐Heng ‐H Pao, Kin‐Man ‐M Kwok, Ming‐Lu ‐L King

研究成果: 雜誌貢獻文章

8 引文 (Scopus)

摘要

Fenoverine is a novel, potent, musculotropic, spasmolytic agent that affects primarily the gastrointestinal tract, bile duct, and female genital organs. A simple, specific, and accurate HPLC method was developed for the determination of fenoverine in capsules and plasma. This method has been successfully applied to stability studies of fenoverine capsules and to a pilot study in a normal, healthy volunteer following oral administration of fenoverine. For the determination of fenoverine in capsules, a Nucleosil 5‐μm CN column, with acetonitrile: 0.1 M ammonium acetate (60:40) as mobile phase and detection at 254 nm, was employed. The mean correlation coefficient of the calibration curve (n = 6) for the assay was 0.9999 over a concentration range of 24.6 to 147.6 μg/mL of fenoverine standard solutions. Fenoverine did not decompose significantly at 4, 45, 55, and 65°C for 3 months. The mean correlation coefficients of within‐day and between‐day calibration curves were 0.9995 and 0.9999, respectively, over a range of 10 to 1000 ng/mL of fenoverine in plasma. The limit of detection was 10 ng in plasma.
原文英語
頁(從 - 到)91-93
頁數3
期刊Journal of Pharmaceutical Sciences
81
發行號1
DOIs
出版狀態已發佈 - 一月 1 1992
對外發佈Yes

指紋

Dosage Forms
Capsules
Smooth Muscle
Calibration
Healthy Volunteers
Female Genitalia
Parasympatholytics
fenoverine
Bile Ducts
Oral Administration
Limit of Detection
Gastrointestinal Tract
High Pressure Liquid Chromatography

ASJC Scopus subject areas

  • Pharmaceutical Science

引用此文

Determination of fenoverine, a modulator of smooth muscle motility, in capsules and in human plasma : Application to dosage form stability and a pilot study in humans. / Hu, Oliver Yoa‐Pu; Chen, Pu‐Hsiang ‐H; Fang, Yaw‐Ju ‐J; Tang, Hung‐Shang ‐S; Pao, Li‐Heng ‐H; Kwok, Kin‐Man ‐M; King, Ming‐Lu ‐L.

於: Journal of Pharmaceutical Sciences, 卷 81, 編號 1, 01.01.1992, p. 91-93.

研究成果: 雜誌貢獻文章

Hu, Oliver Yoa‐Pu ; Chen, Pu‐Hsiang ‐H ; Fang, Yaw‐Ju ‐J ; Tang, Hung‐Shang ‐S ; Pao, Li‐Heng ‐H ; Kwok, Kin‐Man ‐M ; King, Ming‐Lu ‐L. / Determination of fenoverine, a modulator of smooth muscle motility, in capsules and in human plasma : Application to dosage form stability and a pilot study in humans. 於: Journal of Pharmaceutical Sciences. 1992 ; 卷 81, 編號 1. 頁 91-93.
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abstract = "Fenoverine is a novel, potent, musculotropic, spasmolytic agent that affects primarily the gastrointestinal tract, bile duct, and female genital organs. A simple, specific, and accurate HPLC method was developed for the determination of fenoverine in capsules and plasma. This method has been successfully applied to stability studies of fenoverine capsules and to a pilot study in a normal, healthy volunteer following oral administration of fenoverine. For the determination of fenoverine in capsules, a Nucleosil 5‐μm CN column, with acetonitrile: 0.1 M ammonium acetate (60:40) as mobile phase and detection at 254 nm, was employed. The mean correlation coefficient of the calibration curve (n = 6) for the assay was 0.9999 over a concentration range of 24.6 to 147.6 μg/mL of fenoverine standard solutions. Fenoverine did not decompose significantly at 4, 45, 55, and 65°C for 3 months. The mean correlation coefficients of within‐day and between‐day calibration curves were 0.9995 and 0.9999, respectively, over a range of 10 to 1000 ng/mL of fenoverine in plasma. The limit of detection was 10 ng in plasma.",
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