Reverse phase liquid chromatographic determination of bisacodyl in dosage forms. 1985

L P Valenti, and C A Lau-Cam

A method is described for the determination of bisacodyl in enteric-coated tablets and suppositories by liquid chromatography (LC). The method will also determine the hydrolysis degradation products monoacetylbisacodyl and desacetylbisacodyl. The sample is dissolved in 2-propanol, and the extract is diluted with the mobile phase and injected into a liquid chromatograph fitted with a mu Bondapak C18 column and an ultraviolet detector set at 254 nm. The column is eluted with methanol-acetonitrile-0.01M citric acid (25 + 25 + 50). The pooled mean recovery value for bisacodyl from commercial enteric-coated tablets and suppositories was 99.7% with a pooled coefficient of variation (CV) of 0.72%. For content uniformity assays, the CVs were 0.7 and 1.0% for groups of 10 individual commercial suppositories and tablets, respectively. Differences between assay values by the LC and USP XX methods were 0.2% of declared for enteric-coated tablets (n = 5) and 1.0% of declared for suppositories (n = 2). The LC method can determine as little as 0.015 microgram of the monoacetyl or desacetyl degradation product.

UI MeSH Term Description Entries
D001726 Bisacodyl A diphenylmethane stimulant laxative used for the treatment of CONSTIPATION and for bowel evacuation. (From Martindale, The Extra Pharmacopoeia, 30th ed, p871) Agaroletten,Apo-Bisacodyl,Bekunis Bisacodyl,Bicol,Bisac-Evac,Bisacodyl Tannex,Bisacodyl Uniserts,Bisalax,Bisco-Lax,Bisco-Zitron,Dulco-Lax,Dulco-lax perles,Dulcolax,Durolax,Fleet Bisacodyl,Florisan N,Laxagetten,Laxanin,Laxans-ratiopharm,Laxbene,Laxysat Bürger,Lünolax,Rytmil,Ulcolax,ratio-Bisacodyl,Apo Bisacodyl,Bisac Evac,Bisacodyl, Bekunis,Bisacodyl, Fleet,Bisco Lax,Bisco Zitron,Dulco Lax,Dulco lax perles,Dulcolax perles,Laxans ratiopharm,Tannex, Bisacodyl,Uniserts, Bisacodyl,ratio Bisacodyl
D002853 Chromatography, Liquid Chromatographic techniques in which the mobile phase is a liquid. Liquid Chromatography
D003408 Cresols Any of three isomeric crystalline aromatic methylphenols, also known as hydroxytoluenes.
D006868 Hydrolysis The process of cleaving a chemical compound by the addition of a molecule of water.
D013488 Suppositories Medicated dosage forms that are designed to be inserted into the rectal, vaginal, or urethral orifice of the body for absorption. Generally, the active ingredients are packaged in dosage forms containing fatty bases such as cocoa butter, hydrogenated oil, or glycerogelatin that are solid at room temperature but melt or dissolve at body temperature. Rectal Suppositories,Vaginal Suppositories,Vaginal Suppository,Suppositories, Rectal,Suppositories, Vaginal,Suppository, Vaginal
D013608 Tablets, Enteric-Coated Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed) Enteric-Coated Tablets,Tablets, Enteric Coated

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