RESUMO
A selective and reproducible high performance liquid chromatographic method has been developed for the determination of granisetron hydrochloride in presence of its hydrolytic, oxidation, photodecomposition and thermal degradation products. Successful separation of granisetron from its degradation products is achieved on X-Bridge C18 column using acetonitrile: 0.025 M KH2PO4 solution (20:80) adjusted to pH 2 as mobile phase. The method is selective for the determination of granisetron hydrochloride, benzyl alcohol (preservative) and sodium benzoate (preservative) in presence of benzaldehyde; the oxidation product of benzyl alcohol. The method is validated and validation acceptance criteria are met in all cases. Recovery experiments of granisetron hydrochloride, benzyl alcohol and sodium benzoate from a mixture of ICH stress-formed degradation products and benzaldehyde are between 99.5-100.5% with RSD% values less than 1.5%. The proposed validated stability-indicating method is applied to the determination of granisetron and the co-formulated preservatives in tablets, oral solution and injections.
RESUMO
Two simple, fast, environmental friendly and reliable spectrophotometric methods were developed for determination of tapentadol hydrochloride in bulk and synthetic mixture containing the possible excipients. The first method is based on measuring the first derivative values of aqueous solution of the drug at 228 nm (method I) and the second method based on measuring the second derivative values at 235 nm (method II). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of tapentadol 5- 60 μg.ml-1 for both methods. The proposed methods have been extensively validated as per ICH guidelines. The developed spectrophotometric methods in this study are simple, accurate, precise, specific and reproducible and can be directly applied to pharmaceutical dosage form.