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

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 success...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1992-01, Vol.81 (1), p.91-93
Main Authors: Yoa-Pu Hu, Oliver, Chen, Pu-Hsiang, Fang, Yaw-Ju, Tang, Hung-Shang, Pao, Li-Heng, Kwok, Kin-Man, King, Ming-Lu
Format: Article
Language:English
Subjects:
Administration, Oral
Analysis
Biological and medical sciences
Capsules - chemistry
Chromatography, High Pressure Liquid
Drug Stability
General pharmacology
Humans
Medical sciences
Parasympatholytics - administration & dosage
Parasympatholytics - analysis
Parasympatholytics - blood
Pharmacology. Drug treatments
Phenothiazines - administration & dosage
Phenothiazines - analysis
Phenothiazines - blood
Pilot Projects
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Summary: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-μ;m 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 μ;g/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.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.2600810118