About Authors:
T.R.PARTHASARATHI*, M.VANITHA SRI.
BIOANALYTICAL DEPARTMENT,
QUEST LIFE SCIENCES PVT. LTD, SDF III, MEPZ,
TAMBARAM, CHENNAI- 600 045, INDIA.
*parthu_14@yahoo.co.in
ABSTRACT :
A novel isocratic reverse-phase high performance liquid-chromatography method for determination of asenapine maleate was developed and validated after optimization of various chromatographic conditions. Samples were separated on a waters x-terra C18 (100 mm × 4.6 mm, 3.5 μ) analytical column. The mobile phase used was acetonitrile: 0.1M phosphate buffer (pH 3.2) 65:35%v/v operated at 30 °C column oven temperature was pumped at a flow rate of 1.0 mL min−1 and the column eluents were monitored at a wavelength of 272 nm. When sample was injected into the Finnigan surveyor high performance liquid-chromatography system through Finnigan surveyor auto-sampler injector, separation was achieved within 5.0 min. The present method demonstrated was validated with the acceptable values for selectivity, linearity (within the expected concentration range (10–50 μg mL−1; r2 > 0.999)), recovery (>95%), precision (%RSD < 2.0), sensitivity (limit of detection: 1.85 µg mL−1 and lower limit of quantification: 2.34 µg mL−1), robustness, and ruggedness.