Chiral separation of Frovatriptan isomers by HPLC using amylose based chiral stationary phase.
A stereospecific HPLC method for separation of Frovatriptan enantiomers in bulk drug and pharmaceutical formulations was developed and validated on a normal-phase amylose derivertized chiral column. The effects of the organic modifiers namely 2-propanol, ethanol and diethyl amine (DEA) in the mobile phase were optimized to obtain the best enantiomeric separation. Calibration curves were linear over the range of 200-6150 ng/mL, with a regression coefficient (R(2)) of 0.9998. The limit of detection (LOD) and limit of quantification (LOQ) were 65 ng/mL and 200 ng/mL, respectively. The method was accurate and precise and suitable for the intended purpose. Analysis results were compared with the results obtained by using a validated chiral CE method and found to be in very good agreement. This method can be successfully applied to the enantiomeric purity analysis of Frovatriptan in pharmaceutical bulk drug samples and formulations.
Khan
Muzaffar
M
Department of Analytical Research, Dr. Reddy's Laboratories Ltd., Discovery Research, Bollaram Road, Miyapur, Hyderabad 500,049, India. muzaffarkhan76@rediffmail.com
Viswanathan
Balaji
B
Rao
D Sreenivas
DS
Reddy
Rajasekhar
R
D000688:Amylose / Q000737:chemistry*; D002227:Carbazoles / Q000737:chemistry / Q000302:isolation & purification*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017366:Serotonin Receptor Agonists / Q000737:chemistry / Q000302:isolation & purification*; D013237:Stereoisomerism; D014363:Tryptamines / Q000737:chemistry / Q000302:isolation & purification*
D002227:Carbazoles; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; D000688:Amylose; C108128:frovatriptan