Determination of Letrozole in Tablet Formulations by
Reversed Phase High Performance Liquid Chromatography
Mani Ganesh1,2*,
Krishanan Rajasekar2, Margandan
Bhagiyalakshmi1, Mari Vinoba3,
Kavimani Saktimanigandan4, Hyun Tae Jang1
1Department
of Chemical Engineering, Hanseo University, Season
360-706, South Korea, 2Department of Nanotechnology, Biotechnology Centre, Anna University
Coimbatore, Jothipuram, Coimbatore 641-047, India,
3Carbon
Dioxide Reduction & Sequestration Research Center, Korea
Institute of Energy Research, Deajon, 305-343, Korea,
4Alkem Lab Ltd, Taloja-410208, Navi
Mumbai, Maharashtra, India
*Corresponding author:
E-mail:
htjang@hanseo.ac.kr,
chemgans@gmail.com,
mbhagiya@gmail.com
Received: 17 April
2010 Revised
accepted: 30 August 2010
Tropical
Journal of Pharmaceutical Research, October 2010;
9(5):
505-
510
Abstract
Purpose: To develop a simple, rapid, accurate and cost-effective
reversed phase high performance liquid chromatography
(RP-HPLC) method for letrozole in bulk and in tablets.
Methods: Development of a method for the determination of letrozole,
an anti-cancer drug, by RP-HPLC was undertaken using a
new mobile phase of acetonitrile:water (50:50, v/v). The
eluent was monitored at 265 nm.
Results:
The
optimized conditions developed showed a linear response
from 160 to 240 µg/mL, with a correlation coefficient (R2)
of 0.999. The limit of detection (LOD) and limit of
quantification ( LOQ) were 136 and 160 µg/mL,
respectively. The assay values for the two branded
letrozole tablets tested were 99.2 and 100.2 %,
respectively with % relative standard deviation (RSD) of
0.781 and 0.568, respectively. The bench top stability
data of the drug in the mobile phase indicate that the
drug was stable in the mobile phase for 24 h. Recovery
data were good. Placebo study for specificity and
interference of common excipients showed that the method
was specific and free from interfering substances.
Conclusion:
Therefore, the fully validated method developed was
sensitive enough to carry out routine analysis of
letrozole in tablet formulations with regard to its run
time, simplicity of sample preparation and accuracy.
Key words:
Letrozole, Assay, HPLC, Validation, Tablet formulation.
