Indomethacin forms by decomposition two degradation products: 4-chlorobenzoic acid and 5-methoxy-2-methylindoleacetic acid. 4) describes titration method for determination of indomethacin, which is not very convenient in this case for practical use.
They have to be monitored together with an active substance both during manufacturing process and storage of pharmaceuticals. Therefore, high performance liquid chromatography is the method-of-choice enabling determination of active substance and its degradation products during one-step procedure simultaneously and automatically.
Accuracy was in the range of 71.88–92.44.3% and 68.88–84.84% for meat and liver, respectively.
Precision was lower than 10% in all cases indicating that the method can be used as a validated method.
The extent to which method validation (step 5) is investigated will depend on the use of the end analysis; for example, a method required for quality control will require more validation than one developed for a one-off analysis.
The following must be considered when developing an HPLC method: Mobile phase composition, for example, is the most powerful way of optimizing selectivity whereas temperature has a minor effect and would only achieve small selectivity changes.
The method has been applied in a bioequivalence study of two formulation of 500 mg ciprofloxacin.
The wide variety of equipment, columns, eluent and operational parameters involved makes high performance liquid chromatography (HPLC) method development seem complex.
After protein precipitation, chromatographic separation of ciprofloxacin in plasma was achieved at 35 °C with a C18 column and acetonitrile–phosphate mixture, p H 3, as mobile phase.
Even faster separation of standards was obtained with analytical column Zorbax SB-CN (150 mm × 4.6 mm, 5 μm).
The separation was effected with mobile phase of the same composition, only the flow rate was increased to 1.2 ml/min. Both methods use detection wavelength 237 nm and both can use either ketoprofen or flurbiprofen as internal standard for quantitation.
When selecting an HPLC system, it must have a high probability of actually being able to analyse the sample; for example, if the sample includes polar analytes then reverse phase HPLC would offer both adequate retention and resolution, whereas normal phase HPLC would be much less feasible.
Collins English Dictionary - Complete & Unabridged 2012 Digital Edition © William Collins Sons & Co.