BİR SPEKTROFOTOMETRİK İKİLİ KARIŞIM ANALİZİNİN DOĞRULAMA ÇALIŞMASI

Öz

Amaç: Bir sinyal işleme yöntemi uygulanarak hızlı bir spektrofotometrik analiz, gün içi ve günler arası deneyler, standart ekleme tekniği, geri kazanım çalışması ve varyans analizi (ANOVA) ile doğrulanmıştır. Bu amaçla, kandesartan sileksetil (CC) ve hidroklorotiyazidden (HT) oluşan ikili bir farmasötik formülasyon değerlendirildi.

Gereç ve Yöntem: 200-305 nm spektral aralığındaki karışımların ve tablet çözeltilerinin absorpsiyon spektrumları, sabit bir boşluk genişliğine (2 nm) sahip bir Shimadzu UV-1601 çift ışınlı UV-VIS spektrofotometresi ile ölçülmüştür.

Sonuç ve Tartışma: Gün içi ve günler arası deneyler, standart ekleme tekniği, geri kazanım çalışması ve varyans analizi (ANOVA) çalışmaları yapılmış ve bu amaçla yapay karışımlar hazırlanmıştır. Bu çalışmalar yöntemin geçerliliğinin ve uygulanabilirliğinin iyi olduğunu göstermiştir.

Anahtar Kelimeler

• İkili karışım
• kantitatif tayin
• sinyal işleme
• validasyon

VALIDATION STUDY OF A SPECTROPHOTOMETRIC BINARY MIXTURE ANALYSIS

Öz

Objective: A rapid spectrophotometric analysis by applying a signal processing method was validated by intra-day and inter-day experiments, standard addition technique, recovery study and analysis of variance (ANOVA). For this purpose, a binary pharmaceutical formulation was evaluated consisting of candesartan cilexetil (CC) and hydrochlorothiazide (HT).
Material and Method: The absorption spectra of mixtures and tablet solutions in the spectral range 200-305 nm were measured by a Shimadzu UV-1601 dual-beam UV-VIS spectrophotometer with a constant gap width (2 nm).
Result and Discussion: Intra-day and inter-day experiments, standard addition technique, recovery study and analysis of variance (ANOVA) studies were carried out by using artificial mixtures were prepared for this purpose. These studies have shown that the validity and applicability of the method is good.

Anahtar Kelimeler

• Quantitative determination
• Signal processing
• Binary Mixture
• Validation

Kaynakça

1. 1. Siddiqui M. R., AlOthman Z. A., Rahman N. (2017) Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of Chemistry, 10, 1409-1421.
2. 2. Valagaleti R., Burns P.K., Gill M. (2003) Analytical support for drug manufacturing in the United States—from active pharmaceutical ingredient synthesis to drug product shelf life. Drug Inform. J., 37, 407-438.
3. 3. Ju H. (2013) Grand challenges in analytical chemistry: towards more bright eyes for scientific research, social events and human health. Front. Chem., https://doi.org/10.3389/fchem.2013.00005.
4. 4. El-Didamony A. M., Saad M. Z., Saleem N. O. (2015) Spectrophotometric determination of some analgesic drugs in pharmaceutical formulations using N-bromosuccinimide as an oxidant. Journal of the Association of Arab Universities for Basic and Applied Sciences, 17, 43-50.
5. 5. Baghel U. S., Singh A., Singh D. Sinha M. (2017) Application of mass spectroscopy in pharmaceutical and biomedical analysis. Spectroscopic Analyses - Developments and Applications, DOI: 10.5772/intechopen.70655
6. 6. Khateeb L. A., Al-Hakami W.E. (2020) Reliable chromatographic determination of non-steroidal anti-inflammatory drugs in real samples matrices. International Journal of Environmental Analytical Chemistry, https://doi.org/10.1080/03067319.2019.1689967.
7. 7. Baciu T., Botello I., Borrull F., Calull M. Aguilar C. (2015) Capillary electrophoresis and related techniques in the determination of drugs of abuse and their metabolites. TrAC Trends in Analytical Chemistry, 74, 89-108.
8. 8. Özdokur K. V. (2019) Voltammetric determination of isoniazid drug in various matrix by using CuOx decorated mw‐cnt modified glassy carbon electrode. Electroanalysis, https://doi.org/10.1002/elan.201900307.

9. 9. Chhonker Y. S., Edi C., Murry D. J. (2018) LC–MS/MS method for simultaneous determination of diethylcarbamazine, albendazole and albendazole metabolites in human plasma: Application to a clinical pharmacokinetic study. J. Pharm. Biomed. Anal., 20-151, 84–90.
10. 10. Sáiz J., García-Ruiz C., Gómara B. (2017) Comparison of different GC-MS configurations for the determination of prevalent drugs and related metabolites. Analytical Methods, 9, 2897-2908.
11. 11. Maurer H. H. (1994) Toxicological analysis of drugs: GC-MS screening and confirmation. Acta Medicinæ Legalis, XLIV, 489-492.
12. 12. Daubechies I. (1992) Ten Lectures on Wavelets, Society for Industrial and Applied Mathematics, Philadelphia, 1-357.
13. 13. Dinç E., Baleanu D. (2007) Continuous wavelet transform applied to the overlapping absorption signals and their ratio signals for the quantitative resolution of mixture of oxfendazole and oxyclozanide in bolus. J. Food Drug Anal., 15(2), 109-117.
14. 14. Dinç E., Baleanu D., Üstündağ Ö. (2003) An approach to quantitative two-component analysis of a mixture containing hydrochlorothiazide and spironolactone in tablets by one dimensional continuous daubechies and biorthogonal wavelet analysis of UV-spectra. Spectrosc. Lett., 36, 341-355.
15. 15. Redasani V. K., Patel P. R., Marathe D.Y., Chaudhari S. R., Shirkhedkar A. A., Surana S. J. (2018) A revıew on derivative uv-spectrophotometry analysis of drugs in pharmaceutical formulations and biological samples review. Journal of the Chilean Chemical Society, http://dx.doi.org/10.4067/s0717-97072018000304126.
16. 16. Charoo N. A., Bashir M., Abdalla E., Ali K. I. H. (2009) Determination of candesartan cilexetil in tablet dosage forms and dissolution testing samples by first derivative Uv spectrophotometric methods. Anal. Lett. 42(14), 2232-2243.
17. 17. Belal T. S., Daabeesb H. G., Abdel-Khalekb M. M., Mahrousb M. S., Khamisb M. M. (2013) New simple spectrophotometric method for determination of the binary mixtures (atorvastatin calcium and ezetimibe; candesartan cilexetil and hydrochlorothiazide) in tablets. J. Pharm. Anal. 3(2), 118-126.
18. 18. Gangola R., Kaushik S., Sharma P. (2011) Spectrophotometric simultaneous determination of hydrochlorothiazide and telmisartan in combined dosage form. J. Appl. Pharm. Sci. 1, 46-49.
19. 19. Khedr A. E. (2008) Simultaneous determination of candesartan cilexetil and hydrochlorothiazide by high-performance liquid chromatography. J. King Abdulaziz University 15(2), 3-13.
20. 20. Bonthu M. G., Atmakuri L. R., Jangala V. R. (2018) Simultaneous determination of candesartan and hydrochlorothiazide in human plasma by LC-MS/MS. B. J. Pharm. Sci. 54(1), http://dx.doi.org/10.1590/s2175-97902018000117381.
21. 21. Annapurna M. M., Venkatesh B., Chaitanya R. K. (2017) Quality by design approach (QbD) for the simultaneous determination of anti-hypertensive drugs (candesartan, irbesartan and hydrochlorothiazide) by RP-HPLC. Journal of Analytical & Pharmaceutical Research ), http://dx.doi.org/10.15406/japlr.2017.04.00118.