High Performance Liquid Chromatography has been used to evolve an analytical procedure for the evaluation of the content of paracetamol in the bulk, dosage forms and in urine, a body fluid. Separation and resolution have been achieved with a combination of methanol and 2.5% acetic acid (15:85) on a reversed-phase column at ambient temperature. Elution was isocratic with UV detection at 257nm. Internal standard calibration method was used for quantitation with caffeine as the internal standard.Mean retention times for paracetamol and caffeine were respectively 2.61 ± 0.13 min and 11.98 ± 0.72 min . The calibration curve was linear over the range 0.1-5.0μg/ml. The method was also suitable for the assay of paracetamol-codeine combination drug as well as estimation of the amount of constituents in urine when the wavelength of UV detection was 245 nm with acetanilide as the internal standard.
Keywords: Chromatography, isocratic, internal standard, in vivo and in vitro
INTRODUCTIONParacetamol (N-(4-hydroxyphenyl) acetamide) tablets are listed among the essential drugs selected for the health care delivery system in Ghana. Paracetamol is very much used for antipyresis and analgesia without prescription. The drug is useful in mild to moderate pain such as headache, myalgia and postpartum pain. It is a very good alternative for mild to moderate pain in patients who cannot take aspirin because of allergy, haemophilia, history of peptic ulcer and asthma. (Katzung, 1989).As a result of the Ghana government's policy of generic prescribing, the liberalization of trade and import laws, and the ever-increasing number of pharmaceutical industries, a wide range of paracetamol products appear on the Ghanaian market. According to the Ghana National Drugs Policy, only drugs conforming to nationally accepted and/or internationally recognized quality standards shall be permitted to be procured and distributed in the country (Ghana National Drugs Policy, 1999). Any study therefore designed to monitor and improve the quality evaluation of pharmaceutical products both at the time of registration and post-market is very essential in the policy and technical guidelines of drug regulatory authorities such as the Food and Drugs Board. Such a study also benefits the Ghana Health Service in the sense that procurement staff, prescribers, dispensers and patients have access to high-quality and efficacious drug products. Pharmaceutical industries may also have simple analytical procedures for both in-process and finished product evaluations.The HPLC has been used to determine paracetamol in tablets. Franeta et al (2002) used the HPLC for the OH NHCOCH 3 20 simultaneous determination of acetylsalicylic acid, paracetamol, caffeine and phenobarbital in tablets on a reversed-phase column using a mixture of acetonitrile and water (25:75 v/v) adjusted to pH 2.5 with phosphoric acid.The Bio Rad 1801 UV-Vis detector was used (207 nm). Ramos-Martos et al (2001) also described a rapid reversed-phase HPLC method with UV detection for the simultaneou...