Development and Validation of a New Analytical Method for the Determination of Related Components in Quetiapine Hemifumarate

被引:17
|
作者
Raju, I. V. Soma [1 ,3 ]
Raghuram, P. [2 ,3 ]
Sriramulu, J. [3 ]
机构
[1] Invagen Pharmaceut INC, New York, NY 11788 USA
[2] Hetero Labs Ltd, Hyderabad 500018, Andhra Pradesh, India
[3] Sri Krishnadevaraya Univ, Dept Chem, Anantapur 515003, Andhra Pradesh, India
关键词
Column liquid chromatography; Forced degradation; Validation; Quetiapine hemifumarate; PERFORMANCE-LIQUID-CHROMATOGRAPHY; MASS-SPECTROMETRY; HUMAN PLASMA; ANTIDEPRESSANTS; ANTIPSYCHOTICS; ASSAY; SERUM;
D O I
10.1365/s10337-009-1183-z
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A simple, sensitive isocratic rapid resolution liquid chromatographic assay method has been developed for the quantitative determination of quetiapine hemifumarate in bulk active pharmaceutical ingredient, used for the treatment of schizophrenia. The developed method is also applicable for the process related impurities determination. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a isocratic mode and quantification was by ultraviolet detection at 225 nm at a flow rate of 1.0 mL min(-1). In the developed LC method the resolution between quetiapine hemifumarate and its three potential impurities was found to be greater than 2.0. Regression analysis showed an r value (correlation coefficient) greater than 0.99 for quetiapine hemifumarate and its three impurities. This method was capable to detect all three impurities of quetiapine hemifumarate at a level of 0.003% with respect to test concentration of 1.0 mg mL(-1) for a 3 mu L injection volume. The bulk active pharmaceutical ingredient was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur in oxidative stress conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%. The developed RR-LC method was validated with respect to linearity, accuracy, precision and robustness.
引用
收藏
页码:545 / 550
页数:6
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