Development of Analysis and Validation of Human Insulin-Containing Matrices Using Reverse Phase-Liquid Chromatography
DOI:
10.29303/jppipa.v8i5.2305Published:
2022-11-30Issue:
Vol. 8 No. 5 (2022): NovemberKeywords:
Human insulin, Validation, Meta-cresol and glycerol, A-21 desamido insulin, EthylparabeResearch Articles
Downloads
How to Cite
Downloads
Metrics
Abstract
Licensed drugs containing human insulin are used as a routine therapy to maintain blood glucose levels in patients with diabetes mellitus. Meanwhile, production and storage factors can reduce the potency of these drugs, and this is important for patients. Therefore, a fast and reliable analytical method is needed to ensure quality, as well as safety and effectiveness without being affected by the matrices content, such as m-cresol and glycerol. The study was developed with the high-performance liquid chromatography using a reverse-phase column ReliantÔ C-18 (4.6 x 150 mm, 5 mm), 40°C column temperature, 215 nm UV-Vis detector, 1 mL/min flow rate, and 20 mL injection volume, while, ethylparaben was used as an internal standard. Furthermore, the separation was conducted with solution A and B containing Na2SO4 pH 2.3 and Na2SO4 pH 2.3 in acetonitrile (55:45, v/v) in a ratio of 38:62, v/v, while validation was performed according to ICH guideline. The human insulin retention time was 5.04±0.009 minutes, with linearity of 9.74-146.03 mg/mL (r = 0.9997). Accuracy and precision were 100.71±1.11% and 0.64%, while LOD and LOQ were 0.193 mg/mL and 0.643 mg/mL respectively. Human insulin remained stable at 23°C for 48 hours as demonstrated by ANOVA, a0.05. Based on the results, this method has the potential to separate human insulin from A-21 desamido insulin as a degradant and matrices, as well as allowing for testing many products in a short time.
References
Adams, G. G., Meal, A., Morgan, P. S., Alzahrani, Q. E., Zobel, H., Lithgo, R., Kok, M. S., Besong, D. T. M., Jiwani, S. I., Ballance, S., Harding, S. E., Chayen, N., & Gillis, R. B. (2018). Characterisation of insulin analogues therapeutically available to patients. PLOS ONE, 13(3), e0195010. https://doi.org/10.1371/journal.pone.0195010
AOAC. (2016). Guidelines for Standard Method Performance Requirements. Journal of AOAC International and Official Method of Analysis, 9. Retrieved from https://www.aoac.org/resources/guidelines-for-standard-method-performance-requirements/
Atlas, I. D. F. D. (2019). International Diabetes Federation. The Lancet, 266(6881), 134–137. https://doi.org/10.1016/S0140-6736(55)92135-8
Baeshen, N. A., Baeshen, M. N., Sheikh, A., Bora, R. S., Ahmed, M. M. M., Ramadan, H. A. I., Saini, K. S., & Redwan, E. M. (2014). Cell factories for insulin production. Microbial Cell Factories, 13(1), 141. https://doi.org/10.1186/s12934-014-0141-0
Barth, H. G. (2019). Chromatography Fundamentals, Part VIII : The Meaning and Significance of Chromatographic Resolution. 37(11), 824–829. Retrieved from https://www.proquest.com/trade-journals/chromatography-fundamentals-part-viii-meaning/docview/2351559989/se-2?accountid=17242
De Haro Moreno, A., Beatriz Bastos Lucchesi, M., Atala Dib, S., & Regina Nunes Salgado, H. (2018). Development of a New HPLC Method for the Determination of Lispro and Glargine Insulin Analogues in Pharmaceutical Preparations. Journal of Analytical & Pharmaceutical Research, 7(1). https://doi.org/10.15406/japlr.2018.07.00195
European Medicines Agency. (2011). European Medicines Agency: an unacceptable choice. Prescrire International, 20(121), 278. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/22066320
FDA. (2003). Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products, U.S. Department of Health and Human Services, Food and Drug Administration. SubStance, Revision 2, 1–22. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products
Ganji, S., & Satyavati, D. (2015). Development and validation of RP-HPLC method for the analysis of Cobicistat and related impurities in bulk and pharmaceutical dosage forms. Asian Journal of Pharmaceutical Analysis, 5(1), 1. https://doi.org/10.5958/2231-5675.2015.00001.0
Harron, D. W. G. (2013). Technical Requirements for Registration of Pharmaceuticals for Human Use: The ICH Process. In The Textbook of Pharmaceutical Medicine (Vol. 1994, Issue October 1994, pp. 447–460). Blackwell Publishing Ltd. https://doi.org/10.1002/9781118532331.ch23
Iyire, A., Russell, C., Dennison, T., Rajoli, R., Saleem, I., Rahman, A., & Mohammed, A. (2018). Development, Optimisation, Validation and Inter-Laboratory Verification of a Reversed Phase HPLC Method for Quantification of Human Recombinant Insulin. Journal Of Advances In Biotechnology, 7(1), 984–998. https://doi.org/10.24297/jbt.v7i1.7192
Jacob, S., Aly Morsy, M., & Nair, A. (2018). An Overview on the Insulin Preparations and Devices. Indian Journal of Pharmaceutical Education and Research, 52(4), 550–557. https://doi.org/10.5530/ijper.52.4.64
Judák, P., Van Eenoo, P., & Deventer, K. (2018). Utilizing ELISA-plate based immunopurification and liquid chromatography-tandem mass spectrometry for the urinary detection of short- and long acting human insulin analogues. Journal of Pharmaceutical and Biomedical Analysis, 153, 76–81. https://doi.org/10.1016/j.jpba.2018.02.024
Moses, A., Bjerrum, J., Hach, M., Wæhrens, L. H., & Toft, A. D. (2019). Concentrations of Intact Insulin Concurs With FDA and EMA Standards When Measured by HPLC in Different Parts of the Distribution Cold Chain. Journal of Diabetes Science and Technology, 13(1), 55–59. https://doi.org/10.1177/1932296818783783
Moslemi, P., Najafabadi, A. R., & Tajerzadeh, H. (2003). A rapid and sensitive method for simultaneous determination of insulin and A21-desamido insulin by high-performance liquid chromatography. Journal of Pharmaceutical and Biomedical Analysis, 33(1), 45–51. https://doi.org/10.1016/s0731-7085(03)00336-4
Moussa, B. A., Farouk, F., & Azzazy, H. M. E. (2010). A Validated RP-HPLC Method for the Determination of Recombinant Human Insulin in Bulk and Pharmaceutical Dosage Form. E-Journal of Chemistry, 7(s1), S449–S457. https://doi.org/10.1155/2010/147824
Naik, R. A., Kumar, D. A., & Venkatesh, M. (2018). Method Development and Validation of Taurine and Acetyl Cysteine by Using RP-HPLC Method. Asian Journal of Research in Pharmaceutical Science, 8(4), 223. https://doi.org/10.5958/2231-5659.2018.00038.3
Najjar, A., Alawi, M., AbuHeshmeh, N., & Sallam, A. (2014). A Rapid, Isocratic HPLC Method for Determination of Insulin and Its Degradation Product. Advances in Pharmaceutics, 2014, 1–6. https://doi.org/10.1155/2014/749823
Norman, A. W., & Litwack, G. (1997). Pancreatic Hormones: Insulin and Glucagon. In Hormones (pp. 193–227). Elsevier. https://doi.org/10.1016/B978-012521441-4/50008-0
Ravi, S., Peh, K. K., Darwis, Y., Krishna Murthy, B., & Raghu Raj Singh, T. (2007). Development and Validation of an HPLC–UV Method for the Determination of Insulin in Rat Plasma: Application to Pharmacokinetic Study. Chromatographia, 66(9–10), 805–809. https://doi.org/10.1365/s10337-007-0402-8
Shen, Y., Prinyawiwatkul, W., & Xu, Z. (2019). Insulin: a review of analytical methods. The Analyst, 144(14), 4139–4148. https://doi.org/10.1039/c9an00112c
Stationery Office (Great Britain). (2015). British pharmacopoeia 2016: Vol. I. London: Stationery Office. Retrieved from https://www.worldcat.org/formats-editions/927068044
Swamy, G. K., Ravindra, N., & Sowmya, S. (2014). A New RP-HPLC Method Development and Validation for the Simultaneous Estimation of Amlodipine and Valsartan in Tablet Dosage Forms. Asian Journal of Pharmaceutical Analysis, 4(3), 103–107. Retrieved from https://ajpaonline.com/HTMLPaper.aspx?Journal=Asian+Journal+of+Pharmaceutical+Analysis%3BPID%3D2014-4-3-3
Swathi, P., Dutt, K. R., Rao, K. N. V, & Raja, M. A. (2017). RP-HPLC Method Development and Validation for Estimation of Sofosbuvir in Pure and Tablet Dosage Form. Asian Journal of Pharmacy and Technology, 7(3), 153. https://doi.org/10.5958/2231-5713.2017.00025.3
The United States Pharmacopeial Convention. (2019). The United States pharmacopeia: The National formulary. 2299. Retrieved from https://search.library.wisc.edu/catalog/999509774402121
Tokarz, V. L., MacDonald, P. E., & Klip, A. (2018). The cell biology of systemic insulin function. The Journal of Cell Biology, 217(7), 2273–2289. https://doi.org/10.1083/jcb.201802095
Zuben, E. de S. Von, Eloy, J. O., Araujo, V. H. S., Gremião, M. P. D., & Chorilli, M. (2020). Rapid and Sensitive Analytical Method for the Determination of Insulin in Liposomes by Reversed-Phase HPLC. Acta Chimica Slovenica, 67(4), 1273–1280. https://doi.org/10.17344/acsi.2020.6177
Author Biographies
Christy Ambarsari, Fakultas Farmasi, Universitas Indonesia
Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Universitas Indonesia, Kampus UI, Depok 16424, West Java, Indonesia
Herman Suryadi, Fakultas Farmasi, Universitas Indonesia
Departemen Mikrobiologi dan Bioteknologi Farmasi, Fakultas Farmasi, Universitas Indonesia, Kampus UI, Depok 16424, Jawa Barat, Indonesia
Arry Yanuar, Fakultas Farmasi, Universitas Indonesia
Department of Biomedical Computation and Drug Design Laboratory, Faculty of Pharmacy, Universitas Indonesia, Kampus UI, Depok 16424, West Java, Indonesia
License
Copyright (c) 2022 Christy Ambarsari, Herman Suryadi, Arry Yanuar
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with Jurnal Penelitian Pendidikan IPA, agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution 4.0 International License (CC-BY License). This license allows authors to use all articles, data sets, graphics, and appendices in data mining applications, search engines, web sites, blogs, and other platforms by providing an appropriate reference. The journal allows the author(s) to hold the copyright without restrictions and will retain publishing rights without restrictions.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in Jurnal Penelitian Pendidikan IPA.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
