A stability-indicating liquid chromatographic method for Lomustine.
J Pharm Biomed Anal
; 54(1): 213-6, 2011 Jan 05.
Article
em En
| MEDLINE
| ID: mdl-20719460
ABSTRACT
A simple, inexpensive and rapid liquid chromatography (LC) method has been developed for the quantitative determination of Lomustine, an chemotherapy drug. Degradation studies were performed on the bulk drug by heating to 60 °C, exposure to UV light at an energy of 200 Wh/m(2)and to visible light at an illumination of not less than 1.2 million lux hours, acid (0.1N hydrochloric acid), base (0.1N sodium hydroxide) aqueous hydrolysis and oxidation with 6.0% (v/v) hydrogen peroxide. Good resolution between the peaks corresponding to impurities produced during synthesis, degradation products and the analyte was achieved on a Symmetry C 8 LC column using a mobile phase consisting of a mixture of aqueous potassium dihydrogen phosphate and acetonitrile. The degradation samples were assayed against the reference standard of Lomustine and the mass balance in each case was close to 99.9%. Validation of the method was carried out as per International Conference on Harmonization (ICH) requirements.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Química Farmacêutica
/
Cromatografia Líquida
/
Lomustina
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article