Development and validation of a reversed-phase liquid chromatographic method for analysis of estradiol valerate and medroxyprogesterone acetate in a tablet formulation.
A simple and accurate liquid chromatographic method was developed for estimation of estradiol valerate and medroxyprogesterone acetate in pharmaceuticals. Drugs were chromatographed on a reverse phase C18 column, using a mixture (30:70) of ammonium nitrate buffer and acetonitrile and eluants monitored at a wavelength of 280 nm. Solution concentrations were measured on a weight basis to avoid the use of an internal standard. The method was statistically validated for its linearity, accuracy, precision and selectivity. Due to its simplicity and accuracy, the authors believe that the method may be used for routine quality control analysis. It does not require any specific sample preparation except the use of a column guard before the analytical column and suitable prefilter attached to the syringe prior to injection.
Segall
A
A
Cátedra de Control de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Argentina.
Hormaechea
F
F
Vitale
M
M
Perez
V
V
Pizzorno
M T
MT
D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004958:Estradiol / Q000031:analogs & derivatives* / Q000032:analysis; D007202:Indicators and Reagents; D017258:Medroxyprogesterone Acetate / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013607:Tablets
D007202:Indicators and Reagents; D012996:Solutions; D013607:Tablets; D004958:Estradiol; D017258:Medroxyprogesterone Acetate