A validated reversed phase HPLC method for the determination of process-related impurities in almotriptan malate API.
An isocratic reversed phase liquid chromatographic (RP-LC) method has been developed and subsequently validated for the determination of almotriptan malate and its process-related impurities. Separation was achieved with a Phenomenex, Gemini, C-18 column and sodium phosphate buffer (pH adjusted to 7.6): acetonitrile (80:20, v/v) as eluent, at a flow rate of 1.5 mL/min. UV detection was performed at 227 nm. The method is simple, rapid, selective, accurate and stability indicating. The described method is linear over a range of LOQ, 1.5 ug/mL (150% of the specification limit) for all the process-related impurities. The method precision for the determination of related compounds was below 1.0% R.S.D. The accuracy of the method demonstrated at 4 levels in the range of 25-150% of the specification limit and the recovery of impurities were found to be in the range of 96-102%. The method is useful in the quality control of bulk manufacturing.
Kumar
A Phani
AP
Analytical Research, SMS Pharma Research Center, C-23, IE, Sanathnagar, Hyderabad, Andhra Pradesh 500 018, India.
Ganesh
V R L
VR
Rao
D V Subba
DV
Anil
C
C
Rao
B Venugopala
BV
Hariharakrishnan
V S
VS
Suneetha
A
A
Sundar
B Syama
BS
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D014363:Tryptamines / Q000032:analysis*
D014363:Tryptamines; C409045:almotriptan