Validation of an HPLC method for determination of imatinib mesylate in rat serum and its application in a pharmacokinetic study.
A simple, selective, and sensitive liquid chromatographic method has been developed and validated for quantitative determination of Imatinib mesylate in rat serum. Efficient chromatographic separation has been performed on a Zorbax Extend (5 microm, 4.6 x 250 mm) double end-capped C(18) column using a mobile phase consisting of methanol and aqueous triethyl amine (pH 10.5; 1%, v/v) (60:40, v/v) in an isocratic mode at a flow rate of 1 mL/min. Simple and effective liquid-liquid extraction technique has resulted in consistent and high recoveries (90.32-95.86%) at all concentrations studied. The method has demonstrated linearity from 25 to 1600 ng/mL with a regression coefficient of 0.9995. Accuracy of the method is acceptable with intra-batch %bias between -2.34 to 3.42 and inter-batch %bias between -2.17 to 3.45. The method has demonstrated high sensitivity with lower limit of quantification of 25 ng/mL and excellent stability of Imatinib mesylate in serum. The method is found to be rapid, reliable, and suitable for in vivo pharmacokinetic study.
Formulation Development and Pharmacokinetics Laboratory, Pharmacy Group, Birla Institute of Technology and Science, Pilani, 333031 (Rajasthan), India. girish@bits-pilani.ac.in
Girish
G
Bende
Sivacharan
S
Kollipara
Snehalatha
S
Movva
Ganesh
G
Moorthy
Ranendra
R
Saha
D000818:Animals; D001549:Benzamides; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000068877:Imatinib Mesylate; D008297:Male; D010879:Piperazines / Q000097:blood* / Q000493:pharmacokinetics; D011743:Pyrimidines / Q000097:blood* / Q000493:pharmacokinetics; D051381:Rats; D017208:Rats, Wistar
D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate