UV-spectrophotometric determination of imatinib mesylate and its application in solubility studies.
A new, simple and sensitive UV-spectrophotometric method was developed for the determination of imatinib mesylate in bulk and pharmaceutical formulations (tablets and nanoparticles). The developed spectroscopic method was validated for selectivity, linearity and range, precision, accuracy and sensitivity. The method has demonstrated excellent linearity over the range of 2.5-25 microg/mL with regression equation: absorbance (AU) = 0.047 x concentration (microg/mL) + 0.008 and r2 = 0.9998. The developed method demonstrated consistent high recoveries (99-102%) and low relative standard deviation (< 5%) at 285 nm. Moreover, the method was found to be highly sensitive with low limit of detection (0.57 microg/mL) and limit of quantitation (1.71 microg/mL). The apparent molar absorptivity and Sandell's sensitivity was found to be 2.75 x 10(3) L/M cm and 2.15 microg/cm2 respectively. The validated method was successfully employed for the drug content analysis from tablets and nanoparticles preparations. Additionally, the method was successfully employed for pH metric solubility analysis of the drug.
Bende
G
G
Formulation Development and Pharmacokinetics Laboratory, Pharmacy Group, Birla Institute of Technology and Science, Pilani, Rajasthan, India.
Kollipara
S
S
Sekar
V
V
Saha
R
R
D000970:Antineoplastic Agents / Q000032:analysis*; D001549:Benzamides; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D006863:Hydrogen-Ion Concentration; D000068877:Imatinib Mesylate; D053758:Nanoparticles; D010879:Piperazines / Q000032:analysis*; D011743:Pyrimidines / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D012995:Solubility; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D012997:Solvents; D013607:Tablets; D000068877:Imatinib Mesylate