Rapid high pressure liquid chromatographic determination of amitriptyline hydrochloride in tablets and injectables: collaborative study. 1983

S T Walker

A previously reported high pressure liquid chromatographic method for the determination of amitriptyline hydrochloride in dosage forms was modified to permit its use as a stability-indicating method. The modified method, entailing a nitrile bonded microparticulate column, a methanol-0.005M ammonium acetate (90 + 10) mobile phase, and photometric detection at 239 nm, was collaboratively tested by 10 laboratories. Each collaborator received samples of synthetic and commercial tablets and injections. The recovery from a synthetic injection at the 10.06 mg/mL spiking level averaged 98.6%. The amount of declared found in commercial injections averaged 103.1%. The pooled reproducibility SD (CV%) and repeatability SD (CV%) were +/- 2.12 (2.15) and +/- 1.81 (1.84), respectively. The recovery from synthetic tablet composite at the 7.45% spiking level averaged 102.0%. The amount of declared found for commercial 25 mg and 100 mg tablets averaged 96.7 and 97.9%, respectively. The pooled reproducibility SD (CV%) and repeatability SD (CV%) for these 3 tablet samples were +/- 1.89 (1.86) and +/- 1.66 (1.64), respectively. Content uniformity analysis of commercial 25 mg and 100 mg tablets (n = 10) gave amounts of declared values averaging 100.5% (range 92.4-108.8%) and 99.3% (range 89.6-107.0%), respectively. The pooled reproducibility SD (CV%) and repeatability SD (CV%) were +/- 3.23 (3.2) and +/- 2.78 (2.8), respectively. A commercial injectable preparation spiked with dibenzosuberone was also collaboratively analyzed by a thin layer method. The method was adopted interim official first action.

UI MeSH Term Description Entries
D007267 Injections Introduction of substances into the body using a needle and syringe. Injectables,Injectable,Injection
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
D000639 Amitriptyline Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines. Amineurin,Amitrip,Amitriptylin Beta,Amitriptylin Desitin,Amitriptylin RPh,Amitriptylin-Neuraxpharm,Amitriptyline Hydrochloride,Amitrol,Anapsique,Apo-Amitriptyline,Damilen,Domical,Elavil,Endep,Laroxyl,Lentizol,Novoprotect,Saroten,Sarotex,Syneudon,Triptafen,Tryptanol,Tryptine,Tryptizol,Amitriptylin Neuraxpharm,Apo Amitriptyline,Desitin, Amitriptylin,RPh, Amitriptylin
D012996 Solutions The homogeneous mixtures formed by the mixing of a solid, liquid, or gaseous substance (solute) with a liquid (the solvent), from which the dissolved substances can be recovered by physical processes. (From Grant & Hackh's Chemical Dictionary, 5th ed) Solution
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet

Related Publications

S T Walker
January 1987, Journal - Association of Official Analytical Chemists,
S T Walker
January 1985, Journal - Association of Official Analytical Chemists,
S T Walker
January 1984, Journal - Association of Official Analytical Chemists,
S T Walker
January 1985, Journal - Association of Official Analytical Chemists,
S T Walker
January 1987, Journal - Association of Official Analytical Chemists,
S T Walker
July 1983, Journal - Association of Official Analytical Chemists,
S T Walker
January 1989, Journal - Association of Official Analytical Chemists,
Copied contents to your clipboard!