THE OPTIMIZATION OF RP-HPLC CONDITION USING RESPONSE SURFACE METHODOLOGY BOX-BEHNKEN DESIGN FOR SIMULTANEOUS DETERMINATION OF METFORMIN HCL AND GLIMEPIRIDE IN SPIKED PLASMA
DOI:
https://doi.org/10.22159/ijap.2020v12i2.36052Keywords:
Metformin HCl, Glimepiride, RP-HPLC, Spiked plasma, Box-Behnken DesignAbstract
Objective: Aim of this study was to develop and validate the RP-HPLC method using Box-Behnken Design (BBD) for simultaneous analysis metformin HCl and glimepiride in spiked plasma.
Methods: The chromatographic system was comprised of acetonitrile-phosphate buffer 0.0125 M+Sodium Dodecyl Sulphate (SDS) 1 mmol as a mobile phase and Ascentis® Phenyl C18 (250 x 4.6 mm i.d.; 5 µm) column as a stationary phase with UV detector at 210 nm. Three independent variables included phosphate buffer (%), pH and flow rate were optimized using Box-Behnken Design. The observed responses were retention time, peak area and resolution.
Results: The predicted optimum condition of the RP-HPLC system consisted of phosphate buffer solution of 72%, pH at 4.3 and flow rate at 0.8 ml/min. By using this condition, the duration of analysis was more than 18 min, so it was necessary to modify the flow rate to be 1.0 ml/min to get shorter analysis duration. This condition was then applied to analyze metformin and glimepiride in spiked plasma and validated according to the EMA guideline. AUC of interfering components at the IS retention time between 588-1092 mV, the linearity of metformin was 0.9993 and glimepiride was 0.9991, accuracy and precision were between-13.33% until 16.08%, dilution integrity and metformin stability studies were between-4.01% until 11.82%, and for glimepiride stability studies were between-37.48% until-4.76%.
Conclusion: Box-Behnken Design can help optimize the HPLC system, and the optimum condition was valid to analyze metformin and glimepiride in spiked plasma by considering the storage time of plasma samples.
Downloads
References
Wells DA. High throughput bioanalytical sample preparation: methods and automation strategies. 1st. Amsterdam: Elsevier; 2003.
WHO. The top 10 causes of death; 2018. Available from: http://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. [Last accessed on 07 Aug 2018]
Kupsal K, Mudigonda S, Nvbk S, Neelala K. Review: metformin combinatorial therapy for type 2 diabetes mellitus. J Metab Syndr 2016;5:1–8.
Hermann LS, Lindberg G, Lindblad U, Melander A. Efficacy, effectiveness and safety of sulphonylurea-metformin combination therapy in patients with type 2 diabetes. Diabetes Obes Metab 2002;4:296–304.
Davis SN. Chapter 60. insulin, oral hypoglycemic agents, and the pharmacology of the endocrine pancreas. In: Brunton L, Lazo J, Parker L. editors. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. 11thed. USA: McGraw Hill; 2006. p. 1634–40.
Draeger E. Clinical profile of glimepiride. Diabetes Res Clin Pract 1995;28:S139–46.
Fachi MM. Bioanalytical methods for the detection of antidiabetic drugs: a review. Bioanalysis 2017;9:2015–25.
Marangon E, Posocco B, Mazzega E, Toffoli G. Development and validation of high-performance liquid chromatography-tandem mass spectrometry method for the simultaneous determination of irinotecan and its main metabolites in human plasma and its application in a clinical pharmacokinetic study. PLOS One 2015;10:1–18.
Tutunji M, Jarrar O, Musameh M, Alam SM, Quamruzaman, Dham R. Bioequivalence evaluation of two brands of cefaclor 500 mg capsules: quantification of cefaclor using solid-phase extraction technique. J Clin Pharm 2001;26:149–53.
Prabu SL, Suriyaprakash TNK. Extraction of drug from the biological matrix: a review. In: Naik GR. editor. Applied Biological: Engineering-Principles and Practice. London: Intech Open Access Publisher; 2012. p. 479–503.
Abro K, Memon N, Bhanger MI, Perveen S, Panhwar A. Comparative study of electrospray and atmospheric pressure chemical ionization with liquid chromatography-mass spectrometry for quantification of five antihyperglycemic agents utilizing monolithic column. Anal Lett 2012;45:1947–59.
AbuRuz S, Millership J, McElnay J. The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma. J Chromatogr B 2005;817:277–86.
Arayne MS, Sultana N, Tabassum A. RP-LC simultaneous quantitation of co-administered drugs for (non-insulin dependent) diabetic mellitus induced dyslipidemia in active pharmaceutical ingredient, pharmaceutical formulations and human serum with uv-detector. Clin Chim Acta 2013;425:54–61.
Sebaiy MM, Sobhy the -Adl, Baraka MM, Hassan AA. Rapid RP-HPLC method for simultaneous estimation of metformin, pioglitazone, and glimepiride in human plasma. Acta Chromatogr 2018;1–6. Doi:10.1556/1326.2018.00515
Elzanfaly ES, Abdel Gawad S. Simultaneous quantification of ramipril, glimepiride and metformin in human plasma by ultra-performance liquid chromatography–tandem mass spectrometry. J Appl Pharm Sci 2017;7:62–9.
Fachi MM, Cerqueira LB, Leonart LP, Francisco TMG, Pontarolo R. Simultaneous quantification of antidiabetic agents in human plasma by a UPLC–QToF-MS method. PLOS One 2016;11:1–17.
Jing B. Liquid chromatography-electrospray ionization tandem mass spectrometry for simultaneous determination of metformin and glimepiride in beagle dog plasma and bioequivalence study. Chem Res Chin Univ 2012;28:399–405.
Polagani SR, Pilli NR, Gajula R, Gandu V. Simultaneous determination of atorvastatin, metformin and glimepiride in human plasma by LC–MS/MS and Its application to a human pharmacokinetic study. J Pharm Anal 2013;3:9–19.
Sengupta P. LC–MS–MS development and validation for simultaneous quantitation of metformin, glimepiride and pioglitazone in human plasma and its application to a bioequivalence study. Chromatographia 2009;69:1243–50.
Gandjar IG, Rohman A. Drug analysis by spectrophotometry and chromatography. Yogyakarta: Pustaka Pelajar; 2012.
Patil P. HPLC method development-a review. J Pharm Res Educ 2017;1:243–60.
Brouder A, Tietje C. editors. Handbook of Transnational Economic Governance Regimes. Netherlands: Brill; 2009.
Ferreira SLC. Review: box-behnken design: an alternative for the optimization of analytical methods. Anal Chim Acta 2007;597:179–86.
Sahu P. An overview of experimental designs in HPLC method development and validation. J Pharm Biomed Anal 2018;147:590–611.
Gopi G, Kannan K. Formulation development and optimization of nateglinide-loaded ethyl cellulose nanoparticles by box-behnken design. Int J Pharm Pharm Sci 2015;7:310–5.
Saha C, Gupta NV, Chandan RS, Priya S. The development of validated indicating LC-MS method for the determination of tenovir disoproxil fumarate using quality by design approach. Int J Appl Pharm 2019;11:406–17.
Radha S, Sridevi A, Prasad N, Narasimha G. Statistical and kinetic studies of acid protease by aspergillus spp. isolated from soil contaminated with abattoir waste. Int J Pharm Pharm Sci 2018;10:72–9.
Beg S, Kohli K, Swain S, Hasnain MS. Development and validation of RP-HPLC method for quantitation of amoxicillin trihydrate in bulk and pharmaceutical formulations using box-behnken experimental design. J Liq Chromatogr Relat Technol 2012;3:393–406.
Mittal A, Imam A, Parmar S, Gilani S, Taleuzzaman M. Design of experiment based optimized RP-HPLC method for simultaneous estimation of amlodipine and valsartan in bulk and tablet formulations. Austin J Anal Pharm Chem 2015;2:1057–62.
Sahu PK, Swain S, Prasad G, Panda J, Murthy Y. RP-HPLC method for determination of metaxalone using box-behnken experimental design. J Appl Biopharm Pharmacokinet 2014;2:40–9.
Snyder L, Kirkland J, Dolan JW. Introduction to modern liquid chromatography. 3rd. New Jersey: Wiley; 2010.
EMA, Guideline on Bioanalytical Method Validation, European Medicines Agency; 2011.
Prabaningdyah NK, Riyanto S, Rohman A, Siregar C. Application of HPLC and response surface methodology for simultaneous determination of curcumin and desmethoxy curcumin in curcuma syrup formulation. J Appl Pharm Sci 2017;7:58-64.
Purba NB, Rohman A, Martono S. The optimization of HPLC for quantitative analysis of acid orange 7 and sudan II in cosmetic products using box behnken design. Int J Appl Pharm 2019;11:130–7.
Siregar C, Prabaningdyah NK, Choiri S, Riyanto S, Rohman A. Optimization of HPLC using central composite design for determination of curcumin and demethoxycurcumin in tablet dosage form. Dhaka Univ J Pharm Sci 2017;16:137–45.
Zhao LC. Response surface modeling and optimization of accelerated solvent extraction of four lignans from fructus schisandrae. Molecules 2012;17:3618–29.
Bansal G, Singh M, Jindal KC, Singh S. LC–UV–PDA and LC–MS studies to characterize degradation products of glimepiride. J Pharm Biomed Anal 2008;48:788–95.
Published
How to Cite
Issue
Section
