Biomaterial Database

HPLC analysis of indomethacin and its impurities in capsule and suppository formulations. 1982

E Kwong, and G K Pillai, and K M McErlane

Indomethacin and its impurities in suppository and capsule formulations were quantitatively determined by HPLC using a reversed-phase, octadecyl column and a mobile phase of methanol-water-acetonitrile-acetic acid (55:35:10:1). Analysis of the suppository formulations provided a mean potency for indomethacin of 103.8%. The same formulation was found to contain 4-chlorobenzoic acid (0.02%), 5-methoxy-2-methyl-3-indoleacetic acid (0.07%), 4-chlorobenzoic acid-alpha-monoglyceride (0.39%), and indomethacin-alpha-monoglyceride (0.9%) as impurities. The latter two impurities were a result of the interaction of indomethacin and 4-chlorobenzoic acid with glycerin used in the suppository base. Capsule formulations were likewise assayed with an average potency of 99.9 and 101.5% for 25- and 50-mg dosage forms, respectively. Only one of the two capsule formulations examined contained detectable quantities of 4-chlorobenzoic acid (0.05%).

UI	MeSH Term	Description	Entries
D007213	Indomethacin	A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.	Amuno,Indocid,Indocin,Indomet 140,Indometacin,Indomethacin Hydrochloride,Metindol,Osmosin
D002214	Capsules	Hard or soft soluble containers used for the oral administration of medicine.	Capsule,Microcapsule,Microcapsules
D002851	Chromatography, High Pressure Liquid	Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.	Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D004340	Drug Contamination	The presence of organisms, or any foreign material that makes a drug preparation impure.	Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
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