Determination of Nifedipine in Pharmaceutical Preparations by Square Wave Voltammetry Method

Öz

Bu çalışmada, nifedipinin elektroanalitik davranışı döngüsel voltametri yöntemiyle incelenmiştir. Prosedür, susuz çözeltilerde bir platin elektrotta elektrokimyasal olarak oksitlenen nifedipine dayanıyordu. 1.16 V'ta oksidasyon tepe noktası kaydedildi. Nifedipinin oksidasyonunun difüzyon kontrollü olduğu keşfedildi. Ek olarak, farmasötik preparasyonlarda nifedipini belirlemek için bu çalışmada hızlı ve kolay bir Kare Dalga Voltametri yöntemi geliştirildi ve valide edildi. 5 ve 50 µg/mL arasındaki konsantrasyonlarda kalibrasyon eğrisi doğrusaldı. Kesinlik bağıl standart sapma ile verildi ve %3.96'dan azdı. Doğruluk bağıl hata ile verildi ve %2.00'yi geçmedi. Farmasötik preparasyonlarda, nifedipinin ortalama geri kazanımı %100.6'dır. Seçilen deneysel koşullar altında, hiçbir girişim bulunmadı. Önerilen yöntem son derece doğru ve kesindir. Bu nedenle yöntem, farmasötik müstahzar olarak Adalat Crono tabletlerdeki nifedipin ölçümüne uygulanabilir.

Anahtar Kelimeler

• Nifedipine
• voltammetry
• validation
• tablet

Teşekkür

The author also appreciates Semih Yilmaz's assistance with proper English usage.

Kaynakça

1. References [1] Reetu, Ashutosh, Y., Anita, S., Arun, G., (2021) Enhancement of dissolution rate and bioavailability of nifedipine by chitosan based cocrystallization technique, Journal of Pharmaceutical Research International 33(28B), 206-219.
2. [2] Hasanuddin, D.N.A., Garmana, A.N., Sasongko, L., (2024) HPLC method for the determination of nifedipine in rat plasma: development, validation, and application to pharmacokinetic drug-herb interaction study, Pharmacia, 71, 1-6.
3. [3] Choiri1, S., Ainurofiq, A., Ratri, R., Zulmi, M.U., (2018) Analytical method development of nifedipine and its degradants binary mixture using high performance liquid chromatography through a quality by design approach, Materials Science and Engineering, 333, 1-6.
4. [4] Awad, U.Y., Patel, S.K., Kumar, D., Bari, S.A., (2011) Estimation of nifedipine by reverse phase high performance liquid chromatography tablet dosage form, International Journal of Pharmaceutical and Life Sciences, 2, 610-612.
5. [5] Guo, Y., Dai, J., Qian, G., Guo, N., Ma, Z., Guo, X., (2007) Determination of nifedipine in human plasma and its use in bioequivalence study, International Journal of Pharmaceutics, 341, 91-96.
6. [6] Logoyda, L., (2019) Analysis of approaches to the development and validation of the methods of analysis of some active pharmaceutical ingredients from the group of calcium channel blockers in drugs and biological liquids, International Journal of Applied Pharmaceutics, 11, 26-34.
7. [7] Maurer, H.H., Arlt, J.W., (1999) Screening procedure for detection of dihydropyridine calcium channel blocker metabolites in urine as part of a systematic toxicological analysis procedure for acidic compounds by gas chromatography-mass spectrometry after extractive methylation, The Journal of Analytical Toxicology, 23, 73-80.
8. [8] Hemmateenejad, B., Mobaraki, N., Shakerizadeh-Shirazi, F., Miri, R., (2010) Multivariate image analysis-thin layer chromatography (MIA-TLC) for simultaneous determination of co-eluting components, Analyst, 135, 1747-1758.

9. [9] Wang, X.D., Li, J.L., Lu, Y., Chen, X., Huang, M., Chowbay, B., Zhou, S.F., (2007) Rapid andsimultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry: Application to a clinical herb-drug interaction study, Journal of Chromatography A, 852, 534-544.
10. [10] Logoyda, L.S., (2020) LC-MS/MS method development and validation for the determination of nifedipine in human plasma, Biointerface Research in Applied Chemistry, 10(5), 6189-6196.
11. [11] Rahman, N., Azmi, S.N.H., (2006) Validated spectrophotometric method for the assay of nifedipine in bulk and commercial dosage forms, Science Asia, 32, 429-435.
12. [12] Hemmateenejad, B., Miri, R., Kamali, R., (2009) A kinetic spectrophotometric method for determination of amlodipine and nifedipine in pharmaceutical preparations, Journal of the Iranian Chemical Society, 6, 113-120.
13. [13] Richter, P., Toral, M.I., Toledo, C., (2006) Subcritical water extraction and determination of nifedipine in pharmaceutical formulations, The Journal of AOAC International, 89, 365-368.
14. [14] Rahman, N., Azmi S.N., (2005) New spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations, Acta Biochimica Polonica, 52, 915-922.
15. [15] Rahman, N., Hoda, M.N., (2002) Spectrophotometric method for the determination of nifedipine with 4-(methylamino) phenol and potassium dichromate, Il Farmaco, 57, 435-441.
16. [16] El-Hefnawey, G.B., El-Hallag, I.S., Ghoneim, E.M., Ghoneim, M.M., (2004) Voltammetric behavior and quantification of the sedative-hypnotic drug chlordiazepoxide in bulk form, pharmaceutical formulation and human serum at a mercury electrode, Journal of Pharmaceutical and Biomedical Analysis, 34, 75-86.
17. [17] Corti, P., Corbini, G., Gratteri, P., Furlanetto, S., Pinzauti, S., (1994) Determination of some quinolones in tablets, human plasma and urine by differential-pulse polarography, International Journal of Pharmaceutics, 111, 83-87.
18. [18] Dogan, B., Ozkan, S.A., (2005) Electrochemical behavior of carvedilol and its adsorptive stripping determination in dosage forms and biological fluids, Electroanalysis, 17, 2074-2083.
19. [19] Mokhtaria, B., Nematollahia, D., Salehzadehb, H., (2018) Electrochemical simultaneous determination of nifedipine and its main metabolite dehydronifedipine using MWCNT modified glassy carbon electrode, Journal of Molecular Liquids, 264, 543-549.
20. [20] Alghamdi, A.F., (2024) Validation and application of the square wave voltammetry method for the electrochemical determination of eszopiclone in pharmaceutical formulations and human biological fluids using glassy carbon electrode, Journal of King Saud University – Science, 36, 103408.
21. [21] Yilmaz, B., Ekinci, D., (2011) Voltammetric behavior of carvedilol in non-aqueous media and its analytical determination in pharmaceutical preparations, Reviews in Analytical Chemistry, 30, 187-193.
22. [22] Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD, 2001.
23. [23] Rahman, N., Khan, N.A., Azmi, S.N.H., (2004) Extractive spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations using bromocresol green, bromophenol blue, bromothymol blue and eriochrome black T, Il Farmaco, 59, 47-54.
24. [24] Mallick, S., Gupta, B.K., Ghosal, S.K., (1998) Extractive spectrophotometric determination of nifedipine and verapamil hydrochloride, East Pharma, 41, 129-130.
25. [25] The State Pharmacopeia of Ukraine in 3 vol. State Enterprise Ukrainian Scientific Expert Pharmacopoeial Center of the Quality of Medicines 2nd iss. Kharkiv: State Enterprise “Ukrainian Scientific and Experimental Pharmacopoeial Center for the Quality of Medicinal Products, 2015, 1128.
26. [26] El-Walily, A.F.M., (1997) Simultaneous determination of binary mixture of nifedipine andmefruside using derivative spectroscopy, capillary gas-liquid chromatography and high performance liquid chromatography, Acta Pharmaceutica Hungarica, 67, 89-97.
27. [27] Umapathi, P., (1994) Determination of atenolol, nifedipine, aspirin and dipyridamole in tablet preparations by second order derivative spectrophotometry, International Journal of Pharmaceutics, 108, 11-19.
28. [28] Golcu, A.Y., Serin, S., (1998) Spectrophotometric determination of nifedipine via charge transfer complexes, Scientia Pharmaceutica, 66, 341-349.
29. [29] Vyas, S.P., Goswami, S.K., (1993) A sensitive visible spectrophotometric method for the estimation of nifedipine, Indian Drugs, 30, 342-344.