Identification et dosage des impuretés du bénorilate (Salipran) par chromatographie en phase liquide à haute performance

✍ Scribed by G Chevalier; P Rohrbach; C Bollet; M Caude

• Publisher: Elsevier Science
• Year: 1977
• Tongue: English
• Weight: 556 KB
• Volume: 138
• Category: Article
• ISSN: 1873-3778
• DOI: 10.1016/s0021-9673(00)98010-5

✦ Synopsis

Identifzcation and quantitation of impurities from benorilate (Saiipran) by highperformance liquid chromatography

High-performance liquid chromatography is used for identification and quaatitatioa of impurities which may be encountered in a new aatalgic, beaorilate (or Salipran), an ester of aspirin with paracetamol. Gradient elution is carried out using a stationary phase consisting of porous lO-pm silica beads bonded to alkylnitrile (Micropak CN), and a mixture of hexaae-methyleaechloride-methanol-acetic acid with varying methanol percentage as mobile phase. The following impurities were separated from benorilate: acetylsalicylic anhydride, aspirin, acetylsalicylsalicylic acid, salophene, amino4pheaylacetoxy-2-benzoate, paracetamol, p-aminophenol. The repeatability of the quantitative analysis is good with a standard variation of0.54 % for beaorilate (7 injections). Detection is by UV absorption at 254 nm, and detectability is between 2 -10m9 moles for p-aminophenol and 4-10-l' moles for salophene.