Abstract
Sitagliptin, an oral antidiabetic drug, is an effective medication for lowering blood glucose level either as monotherapy or in combination with other antidiabetic drugs. This work aims for the fabrication of a potentiometric sensor for sitagliptin detection. The sensor was designed by doping the polyvinyl chloride polymeric ion-selective membrane with calix[4]arene as an ionophore which highly improved the linearity range (1 × 10−6—1 × 10−2 M), sensitivity, selectivity and limit of detection (6.3 × 10−7 M) compared to ionophore-free membrane. The method was then validated according to the International Council for Harmonization (ICH) guidelines. The sensor was successfully employed to determine sitagliptin in bulk and pharmaceutical dosage form without any pre-treatment steps. Moreover, to demonstrate the deployability of the proposed sensor; it has been applied for the dissolution testing of sitagliptin by in-line continuous monitoring of sitagliptin release as a function of time from the pharmaceutical dosage form into the dissolution medium. This in-line dissolution monitoring has many advantages such as there is no need for the frequent sampling followed by the complicated procedures of samples treatment. Finally, the proposed potentiometric method was evaluated using the analytical eco-scale and has proved to be excellent green analysis in which solvent consumption and pre-treatment of samples were not necessary for its application.
Graphic abstract
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Data availability
All data generated or analyzed during this study are included in this published article.
References
Abd El-Rahman MK, Mazzone G, Mahmoud AM, Sicilia E, Shoeib T (2021) Novel choline selective electrochemical membrane sensor with application in milk powders and infant formulas. Talanta 221:121409. https://doi.org/10.1016/j.talanta.2020.121409
Ahmed DA, El-Rahman MKA, Lotfy HM, Weshahy SA (2018) Double-dip approach: Simultaneous dissolution profiling of pseudoephedrine and ibuprofen in a combined dosage form by ion selective electrodes. J Electrochem Soc 165:H999–H1003. https://doi.org/10.1149/2.1291814jes
Bakker E, Bühlmann P, Pretsch E (1997) Carrier-based ion-selective electrodes and bulk optodes. 1. general characteristics. Chem Rev 97:3083–3132. https://doi.org/10.1021/cr940394a
Balamurugan K, Mishra K (2018) Sitagliptin: a literature review on analytical and bio- analytical methods. Pharma Innov J 7:357–361
Barseem A, Ahmed H, El-Shabrawy Y, Belal F (2019) The use of SDS micelles as additive to increase fluorescence analysis of sitagliptin and saxagliptin derivatives in their tablets and human plasma. Microchem J 146:20–24. https://doi.org/10.1016/j.microc.2018.12.054
Bühlmann P, Pretsch E, Bakker E (1998) Carrier-based ion-selective electrodes and bulk optodes. 2. ionophores for potentiometric and optical sensors. Chem Rev 98:1593–1688. https://doi.org/10.1021/CR970113+
Chavhan V, Kadam A (2013) UV Spectrophotometric method development and validation for estimation of sitagliptin phosphate in bulk and tablet dosage form by absorption ratio and area under the curve method. J Biol Sci Opin 1:317–322. https://doi.org/10.7897/2321-6328.01407
Dressman J, Kramer J (2005) Pharmaceutical dissolution testing. Taylor & Francis Group, Florida
El-Hanboushy S, El-Rahman MKA, Fayez YM, Lotfy HM, Abdelkawy M (2019) Real time selective monitoring of the dissolution behavior of pseudoephedrine sulfate and loratadine in their binary and ternary dosage form by utilization of In-line potentiometric sensor. J Electrochem Soc 166:B610–B617. https://doi.org/10.1149/2.0741908jes
El-Kosasy AM, Aziz LAE, Trabik Y (2012) Comparative study of beta cyclodextrin and calix-8-arene as ionophores in potentiometric ion-selective electrodes for sitagliptin phosphate. J Appl Pharm Sci 2:51–56. https://doi.org/10.7324/JAPS.2012.2806
El-Mosallamy SS, Ahmed K, Daabees HG, Talaat W (2020) A microfabricated potentiometric sensor for metoclopramide determination utilizing a graphene nanocomposite transducer layer. Anal Bioanal Chem 412:7505–7514. https://doi.org/10.1007/s00216-020-02884-2
Elhassan MM, Mahmoud AM, Hegazy MA, Mowaka S (2021) Electrochemical determination of ipragliflozin in pure form and in spiked human plasma on a glassy carbon electrode. J Electrochem Soc 168:036507. https://doi.org/10.1149/1945-7111/abe511
Elsayed GM, El Mously DA, Mostafa NM, Hassan NY, Mahmoud AM (2020) Neostigmine potentiometric sensors based on microfabricated copper electrodes using Poly(3-octylthiophene) as an ion-to-electron transducer layer. J Electrochem Soc 167:137506. https://doi.org/10.1149/1945-7111/abb8f6
Emami J (2006) In vitro - in vivo correlation: from theory to applications. J Pharm Pharm Sci 9:169–189
Forbes JM, Cooper ME (2013) Mechanisms of diabetic complications. Physiol Rev 93:137–188. https://doi.org/10.1152/physrev.00045.2011
Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J (2012) Analytical eco-scale for assessing the greenness of analytical procedures. TrAC - Trends Anal Chem 37:61–72. https://doi.org/10.1016/j.trac.2012.03.013
Gholami M, Ghasemi AM, Loghavi MM, Behkami S, Ahamdi-Dokht-Faraghe A (2013) Preparation of a miniaturised iodide ion selective sensor using polypyrrole and pencil lead: effect of double-coating, electropolymerisation time, and current density. Chem Pap 67:1079–1086. https://doi.org/10.2478/s11696-013-0342-8
Gracea AC, Prabhaa T, Jagadeeswarana M, Srinivasan K, Sivakumarb T (2017) Analytical methods for determination of sitagliptin: an updated review. Int J Pharm Sci Rev Res 43:217–225
Hassan SA, ElDin NB, Zaazaa HE, Moustafa AA, Mahmoud AM (2020) Point-of-care diagnostics for drugs of abuse in biological fluids: application of a microfabricated disposable copper potentiometric sensor. Microchim Acta 187:1–9. https://doi.org/10.1007/s00604-020-04445-x
Hinnen D (2017) Glucagon-like peptide 1 receptor agonists for type 2 diabetes. Diabetes Spectr 30:202–210. https://doi.org/10.2337/ds16-0026
Jeyabalan G, Nyola N (2013) Analytical method development and validation of sitagliptine phosphate monohydrate in pure and tablet dosage form by derivative spectroscopy. J Appl Pharm Sci 3:95–98. https://doi.org/10.7324/JAPS.2013.30118
Kamel AH, Galal H (2014) MIP-based biomimetic sensors for static and hydrodynamic potentiometric transduction of sitagliptin in biological fluids. Int J Electrochem Sci 9:4361–4373
Kharroubi A, Darwish H (2015) Diabetes mellitus: the epidemic of the century. World J Diabetes 6:850–867. https://doi.org/10.4239/WJD.V6.I6.850
Lange ADC, Batistel AP, Sfair LL, Carlosso J, Volpato NM, Schapoval EES (2014) Sitagliptin phosphate: development of a dissolution method for coated tablets based on in vivo data for improving medium sensitivity. Dissolution Technol 21:17–22. https://doi.org/10.14227/DT210214P17
Lavanya R, Yunoos M (2013) Development and validation of RP-HPLC method for the estimation of sitagliptin phosphate in bulk and its tablet dosage form. J Adv Pharm Educ Res 3:475–479
Lotfy HM, Hegazy MAM, Abdel-Gawad SAN (2013) Simultaneous determination of simvastatin and sitagliptin in tablets by new univariate spectrophotometric and multivariate factor based methods. Eur J Chem 4:414–421. https://doi.org/10.5155/eurjchem.4.4.414-421.829
Lotfy HM, Mohamed D, Mowaka S (2015) A comparative study of smart spectrophotometric methods for simultaneous determination of sitagliptin phosphate and metformin hydrochloride in their binary mixture. Spectrochim Acta - Part A Mol Biomol Spectrosc 149:441–451. https://doi.org/10.1016/j.saa.2015.04.076
Luo H, Chen LX, Ge QM, Liu M, Tao Z, Zhou YH, Cong H (2019) Applications of macrocyclic compounds for electrochemical sensors to improve selectivity and sensitivity. J Incl Phenom Macrocycl Chem 95:171–198
Mahmoud AM, Ragab MT, Ramadan NK, El-Ragehy NA, El-Zeany BA (2020) Design of solid-contact ion-selective electrode with graphene transducer layer for the determination of flavoxate hydrochloride in dosage form and in spiked human plasma. Electroanalysis 32:2803–2811. https://doi.org/10.1002/elan.202060377
Matveichuk Y, Rakhman’ko E, Akayeu Y (2018) Chemically modified (Poly)vinyl chloride with built-in neutral carrier function as a new material for ion selective electrodes. Chem Pap 72:1315–1323. https://doi.org/10.1007/s11696-017-0356-8
Matveichuk Y, Rakhman’ko E, Akayeu Y, Stanishevskii D (2018) Ion-selective electrodes based on long-chain quaternary ammonium salts with enhanced steric accessibility, and their application for determination of hydrophilic double-charged inorganic anion. Chem Pap 72:731–739. https://doi.org/10.1007/s11696-017-0320-7
Mohamed HM, Lamie NT (2016) Analytical eco-scale for assessing the greenness of a developed RP-HPLC method used for simultaneous analysis of combined antihypertensive medications. J AOAC Int 99:61–72. https://doi.org/10.5740/jaoacint.16-0124
Morgan EM, El-Rahman MKA, Lotfy HM, Fayez YM, Abdelkawy M (2019) Potentiometric sensing of valaciclovir hydrochloride in the presence of its Acid induced degradation product with real time acquisition of the dissolution profile from its pharmaceutical formulations. J Electrochem Soc 166:B866–B872. https://doi.org/10.1149/2.0111912jes
Mousavi MPS, Abd El-Rahman MK, Mahmoud AM, Abdelsalam RM, Bühlmann P (2018) In situ sensing of the neurotransmitter acetylcholine in a dynamic range of 1 nM to 1 mM. ACS Sens 3:2581–2589. https://doi.org/10.1021/acssensors.8b00950
Mowaka S, Mohamed D (2015) Novel contribution to the simultaneous analysis of certain hypoglycemic drugs in the presence of their impurities and degradation products utilizing UPLC-MS/MS. RSC Adv 5:60467–60481. https://doi.org/10.1039/c5ra11448a
Pantić ID, Mihajlović RP, Mihajlović LV (2010) A deuterium-palladium electrode as a new sensor in non-aqueous solutions: potentiometric titration of weak acids in acetonitrile and benzonitrile. Chem Pap 64:541–549. https://doi.org/10.2478/s11696-010-0044-4
Patil S, Ramesh B, Hareesh AR, Patil K, Dhokane A (2010) Development and validation of RP-HPLC method for the estimation of sitagliptin phosphate in tablet dosage form. Asian J Res Chem 3:653–655
Pritam J, Amar C, Bhargav D, Shani P, Santsaran P, Hiren S, Amol C (2011) Development and validation of first order derivative UV-Spectrophotometric method for determination of sitagliptin in bulk and in formulation. Int J Drug Dev Res 3:194–199
Ramadan M (2014) O-phthalaldehyde based spectrophotometric method for determination of sitagliptin in tablets. Int J Pharm Pharm Sci 6:125–129
Ramadoss R, Kiranmayi P, Chowdary IV, Saravanan S (2014) Development and validation of RP-HPLC method for content analysis and dissolution studies of sitagliptin phosphate monohydratein pharmaceutical dosage forms. Res J Pharm Biol Chem Sci 5:133–140
Riad S, Rezk M, Mahmoud GY, Abdel Aleem A-AEB (2013) A selective sensor for determination of sitagliptin phosphate in pharmaceutical formulation. Anal Bioanal Electrochem 5:416–425
Safwat N, Mahmoud AM, Abdel-Ghany MF, Ayad MF (2021) In situ monitoring of triclosan in environmental water with subnanomolar detection limits using eco-friendly electrochemical sensors modified with cyclodextrins. Environ Sci Process Impacts 23:457-466. https://doi.org/10.1039/d0em00387e
Salim MM, El-Enany N, Belal F, Walash MI, Patonay G (2014) Micelle-enhanced spectrofluorimetric method for determination of sitagliptin and identification of potential alkaline degradation products using LC-MS. Luminescence 29:65–73. https://doi.org/10.1002/bio.2503
Salmon L, Thuéry P, Ephritikhine M (2006) Uranium(IV) complexes of calix[n]arenes (n = 4, 6 and 8). Chem Commun. https://doi.org/10.1039/b516438a
Sekaran CB, Rani AP (2010) Development and validation of spectrophotometric method for the determination of DPP-4 inhibitor, sitagliptin, in its pharmaceutical preparations. Eclet Quim 35:45–53. https://doi.org/10.1590/S0100-46702010000300003
Sireesha D, Lakshmi ES, Sravya E, Bakshi V (2017) Development and validation of RP-HPLC method for the estimation of sitagliptin phosphate in tablet dosage form. Int J Appl Pharm Sci Res 2:41–45. https://doi.org/10.21477/ijapsr.v2i3.8099
Sohajda T, Hu WH, Zeng LL, Li H, Szente L, Noszál B, Béni S (2011) Evaluation of the interaction between sitagliptin and cyclodextrin derivatives by capillary electrophoresis and nuclear magnetic resonance spectroscopy. Electrophoresis 32:2648–2654. https://doi.org/10.1002/elps.201000639
Sreedhar C, Manogna K, Rao TS, Akkamma H (2012) New analytical method development and validation of some oral hypoglycemic drugs. Res J Pharm Biol Chem Sci 3:20–30
Stoll VS, Blanchard JS (1990) Buffers: principles and practice. Methods Enzymol 182:24–38. https://doi.org/10.1016/0076-6879(90)82006-N
Sushma G, Sri Harsha D, Mukthinuthalapati MA (2020) New first derivative spectrophotometric methods for the determination of sitagliptin-an antidiabetic agent. Res J Pharm Technol 13:2838–2842. https://doi.org/10.5958/0974-360X.2020.00505.3
Uçaktürk E (2013) Development of a gas chromatography-mass spectrometry method for the analysis of sitagliptin in human urine. J Pharm Biomed Anal 74:71–76. https://doi.org/10.1016/j.jpba.2012.10.012
Xiao KP, Bühlmann P, Nishizawa S, Amemiya S, Umezawa Y (1997) A chloride ion-selective solvent polymeric membrane electrode based on a hydrogen bond forming ionophore. Anal Chem 69:1038–1044. https://doi.org/10.1021/ac961035d
(1996) ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Current step 4 version, Parent guidelines on Methodology
Funding
The authors received no specific funding for this work.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflicts of interest
There are no conflicts to declare.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Elhassan, M.M., Mahmoud, A.M., Hegazy, M.A. et al. In-line monitoring of sitagliptin dissolution profile from tablets utilizing an eco-friendly potentiometric sensor. Chem. Pap. 75, 4165–4176 (2021). https://doi.org/10.1007/s11696-021-01646-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11696-021-01646-3