METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IDELALISIB IN RABBIT PLASMA BY HPLC

被引：8

作者：

Suneetha, A. ^{[1
]}

Sharmila, D. ^{[2
]}

机构：

[1] Hindu Coll Pharm, Dept Pharmaceut Anal, Amaravathi Rd, Guntur 522002, Andhra Pradesh, India

[2] VV Inst Pharmaceut Sci, Dept Pharmaceut Anal, Gudlavalleru 521356, Andhra Pradesh, India

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH | 2016年 / 7卷 / 12期

关键词：

Idelalisib; Ibrutinib; Anticaner; Rabbit Plasma;

D O I：

10.13040/IJPSR.0975-8232.7(12).4998-05

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A simple, rapid, sensitive, and accurate high performance liquid chromatography was developed for determination of Idelalisib (IL) in rabbit plasma using Ibrutinib as internal standard (IS). Idelalisib is a phosphoinositide 3-kinase inhibitor indicated in the treatment of chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). The analytes and IS were separated on a ODS (250 mm x 4.6 mm, 5 mu m) column using Mobile phase composition as Buffer and Acetonitrile in the ratio of 85: 15 v/v%. The total chromatographic runtime is 10.0 min with retention time for IL and IS at 7.195, and 5.435 min, respectively with a flow rate 1ml/min. The method is validated over a dynamic linear range of 0.02-4 mu g/mL for IL with a correlation coefficient of r2 0.999. The method was validated as per the USFDA guidelines and the results were within the acceptance criteria for selectivity, sensitivity, linearity, precision, accuracy, recovery stability of solution and stability of solution in plasma.

引用

页码：4998 / 5005

页数：8

共 10 条

[1]

Brown Jennifer R., 2014, BLOOD, V123, P3390

[2] BTK inhibition targets in vivo CLL proliferation through its effects on B-cell receptor signaling activity [J].

Cheng, S. ;

Ma, J. ;

Guo, A. ;

Lu, P. ;

Leonard, J. P. ;

Coleman, M. ;

Liu, M. ;

Buggy, J. J. ;

Furman, R. R. ;

Wang, Y. L. .

LEUKEMIA, 2014, 28 (03) :649-657

[3]

Furman Richard R., 2014, NEW ENGLAND J MED, V370

[4] Idelalisib for the treatment of non-Hodgkin lymphoma [J].

Graf, Solomon A. ;

Gopal, Ajay K. .

EXPERT OPINION ON PHARMACOTHERAPY, 2016, 17 (02) :265-274

[5] Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia [J].

Maddocks, Kami J. ;

Ruppert, Amy S. ;

Lozanski, Gerard ;

Heerema, Nyla A. ;

Zhao, Weiqiang ;

Abruzzo, Lynne ;

Lozanski, Arletta ;

Davis, Melanie ;

Gordon, Amber ;

Smith, Lisa L. ;

Mantel, Rose ;

Jones, Jeffrey A. ;

Flynn, Joseph M. ;

Jaglowski, Samantha M. ;

Andritsos, Leslie A. ;

Awan, Farrukh ;

Blum, Kristie A. ;

Grever, Michael R. ;

Johnson, Amy J. ;

Byrd, John C. ;

Woyach, Jennifer A. .

JAMA ONCOLOGY, 2015, 1 (01) :80-87

[6]

National Center for Biotechnology Information, PUB CHEM COMP DAT

[7]

National Center for Biotechnology Information PubChem, PUBCHEM COMP DAT

[8]

Raedler Lisa A, 2015, Am Health Drug Benefits, V8, P157

[9] Clinical Pharmacokinetic and Pharmacodynamic Profile of Idelalisib [J].

Ramanathan, Srinivasan ;

Jin, Feng ;

Sharma, Shringi ;

Kearney, Brian P. .

CLINICAL PHARMACOKINETICS, 2016, 55 (01) :33-45

[10]

US Department of Health and Human Services FDA Center for Drug Evaluation and Research Center for Veterinary Medicine, 2001, GUID IND BIOAN METH

← 1 →