A selective and sensitive stability-Indicating HPLC method for the validated assay of etoposide from commercial dosage form and polymeric tubular nanocarriers

被引:11
作者
Algan, Aslihan Hilal [1 ]
Gumustas, Mehmet [2 ]
Karatas, Aysegul [1 ]
Ozkan, Sibel A. [2 ]
机构
[1] Ankara Univ, Dept Pharmaceut Technol, Fac Pharm, TR-06100 Ankara, Turkey
[2] Ankara Univ, Dept Analyt Chem, Fac Pharm, TR-06100 Ankara, Turkey
关键词
Etoposide; HPLC; Validation; Template wetting method; Tubular nanocarriers; Drug release; DELIVERY; NANOTUBES; NANOPARTICLES; VEHICLES;
D O I
10.1016/j.jpba.2016.03.007
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Etoposide is a topoisomerase II enzyme inhibitor type chemotherapeutic agent which is widely used in the therapy of various cancers. Its short half-life and toxicity to normal tissues are the major drawbacks in its clinical applications. Polymeric nanoparticulate drug delivery systems are rational carriers to deliver etoposide with higher efficiency and fewer side effects. In addition tubular shaped drug carriers are found to show a great potential for drug delivery on the basis of promising results regarding particle shape and cellular uptake. In this study, etoposide loaded polymeric tubular nanocarriers have been developed by template wetting method using porous anodic aluminum oxide membranes as templates. The developed poly(methyl methacrylate) nanocarriers were evaluated for structural analysis, in vitro drug release studies and drug release kinetics. Accurate and reliable determination of the drug release from newly developed nanocarriers, is of great importance. For this reason a selective and sensitive reversed phase liquid chromatography method was developed and fully validated from the point of system suitability, specificity, linearity and range, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy and robustness for the reliable determination of etoposide. Stability. indicating capability was shown with forced degradation studies and the chromatographic conditions were optimized on ACE 5C18 (150 mm x 4.6 mm 5 mu m) analytical column. Related to the calibration results ETP was found linear in the range between 0.2 from 100 mu g mL(-1) with the LOD as 0.015 mu g.mL(-1). The resultant conditions were applied for the selective and sensitive determination of etoposide from its commercial dosage form with the high accuracy values (99.82-100.65%). The method was successfully detected assay of etoposide release from newly developed polymeric tubular nanocarriers, which was found as 72.2% at the end of 24 h. (C) 2016 Elsevier B.V. All rights reserved.
引用
收藏
页码:382 / 389
页数:8
相关论文
共 30 条
[1]  
[Anonymous], 2000, ICH GUIDELINE Q1AR S
[2]  
[Anonymous], 2005, ICH GUIDEKINE Q2A R1
[3]  
Baldwin E. L., 2005, Current Medicinal Chemistry - Anti-Cancer Agents, V5, P363, DOI 10.2174/1568011054222364
[4]   Poly(methyl methacrylate) particulate carriers in drug delivery [J].
Bettencourt, Ana ;
Almeida, Antonio J. .
JOURNAL OF MICROENCAPSULATION, 2012, 29 (04) :353-367
[5]   Particle shape: A new design parameter for micro- and nanoscale drug delivery carriers [J].
Champion, Julie A. ;
Katare, Yogesh K. ;
Mitragotri, Samir .
JOURNAL OF CONTROLLED RELEASE, 2007, 121 (1-2) :3-9
[6]   Modeling and comparison of dissolution profiles [J].
Costa, P ;
Manuel, J ;
Lobo, S .
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2001, 13 (02) :123-133
[7]  
Dash S, 2010, ACTA POL PHARM, V67, P217
[8]   Evaluation of drug delivery characteristics of microspheres of PMMA-PCL-cholesterol obtained by supercritical-CO2 impregnation and by dissolution-evaporation techniques [J].
Elvira, C ;
Fanovich, A ;
Fernández, M ;
Fraile, J ;
San Román, J ;
Domingo, C .
JOURNAL OF CONTROLLED RELEASE, 2004, 99 (02) :231-240
[9]   Factors controlling the pharmacokinetics, biodistribution and intratumoral penetration of nanoparticles [J].
Ernsting, Mark J. ;
Murakami, Mami ;
Roy, Aniruddha ;
Li, Shyh-Dar .
JOURNAL OF CONTROLLED RELEASE, 2013, 172 (03) :782-794
[10]   Optimization of a validated stability-indicating RP-LC method for the determination of fulvestrant from polymeric based nanoparticle systems, drugs and biological samples [J].
Gumustas, Mehmet ;
Sengel-Turk, Ceyda Tuba ;
Hascicek, Canan ;
Ozkan, Sibel A. .
BIOMEDICAL CHROMATOGRAPHY, 2014, 28 (10) :1409-1417