Research Article
BibTex RIS Cite

FARMASÖTİK BİR PREPARATTAKİ İKİLİ KARIŞIMIN SPEKTROFOTOMETRİK SİNYAL İŞLEME TEKNİĞİ KULLANILARAK AYNI ANDA MİKTAR TAYİNİ VE VALİDASYONU

Year 2020, , 506 - 516, 30.09.2020
https://doi.org/10.33483/jfpau.799897

Abstract

Amaç: Bu çalışmada, tablette irbesartan (IRB) ve hidroklorotiyazidin (HCT) aynı anda miktar tayini için hızlı ve güçlü bir sinyal işleme yaklaşımı, spektrum oranları türev spektrofotometri (RDS) yöntemi geliştirilmiştir. RDS yöntemi, IRB ve HCT'nin UV spektrumlarına uygulanmıştır.
Gereç ve Yöntem: Kalibrasyon denklemleri, sırasıyla IRB tayini için 236.3 nm'de ve HCT tayini için 260.0 nm'de ölçülerek elde edilmiştir. Önerilen yöntem, geri kazanım çalışmaları, gün içi ve günler arası testler ve standart ekleme tekniği kullanılarak doğrulanmıştır.
Sonuç ve Tartışma: Bu çalışma, IRB ve HCT'nin sentetik karışımları ve tabletlerinde aynı anda miktar tayini için hızlı ve güçlü bir sinyal işleme yöntemi uygulamayı amaçlamaktadır. Görülebileceği gibi, iki ilacın UV spektrumları aynı spektral bölgede güçlü bir şekilde örtüşmektedir. Doğrudan geleneksel absorbans ölçümleri, spektral girişim nedeniyle IRB-HCT tablet analizi için beklenen sonuçları vermemektedir. Bununla birlikte, makul bir spektral analiz sonucuna ulaşmak için, esas olarak spektrum oranları türev spektrofotometri işleminin IRB-HCT karışımlarının kantitatif tayinine bir ayırma prosedürüne gerek kalmadan uygulanmasına odaklanılmıştır.

References

  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Maurer H. H. (1994) Toxicological analysis of drugs: GC-MS screening and confirmation. Acta Medicinæ Legalis, XLIV, 489-492.
  • 12. Daubechies I. (1992) Ten Lectures on Wavelets, Society for Industrial and Applied Mathematics, Philadelphia, 1-357.
  • 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. 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. 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. Albero I., Rodenas V., Garcia S., Sanchez C. (2002) Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry. J. Pharmaceut. Biomed., 29(1-2), 299-305.
  • 17. El-Yazbi A., Hammud H., Sonji M. (2007) Analysis of eprosartan-hydrochlorothiazide and irbesartan -hydrochlorothiazide binary mixtures by derivative spectrophotometry. Int. J. App. Chem., 3(1), 1-12.
  • 18. Joseph J., Brault S., Boyer C., Langlois M., Cabrero L., Dubost J. (2003) Simultaneous determination of irbesartan and hydrochlorothiazide in tablets by derivative spectrophotometry. Anal. Lett., 36(11), 2485-2495.
  • 19. Zhu J., You S., Meng X. (2003) Determination of irbesartan and hydrochlorothiazide in compound irbesartan tablets by HPLC. Zhongguo Yiyao Gongye Zazhi, 34(11), 567-569.
  • 20. Tutunji L. F., Tutunji M. F., Alzoubi M. I., Khabbas M. H., Arida A. I. (2009) Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma using HPLC coupled with tandem mass spectrometry:Application to bioequivalence studies. J. Pharmaceut. Biomed., 51(4), 985-990.
  • 21. Alanazi A. M., Abdelhameed A. S., Khalil N.Y., Khan A. A., Darwish I. A. (2014) HPLC method with monolithic column for simultaneous determination of irbesartan and hydrochlorothiazide in tablets. Acta Pharm., 64, 187-198.
  • 22. Kalyani G., Adjuad B. (2019) Stability indicating assay and estimation of irbesartan by first order uv derivative spectrophotometry. International Journal of Pharmaceutical Sciences and Research, 23, 3817-3821.

SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE

Year 2020, , 506 - 516, 30.09.2020
https://doi.org/10.33483/jfpau.799897

Abstract

Objective: In this context, a rapid and powerful signal processing approach, a ratio-derivative spectrophotometry (RDS) method were developed for the simultaneous determination of irbesartan (IRB) and hydrochlorothiazide (HCT) in a tablet.
Material and Method: The RDS method was applied to the UV spectra of the IRB and HCT. The calibration equations were obtained by measuring amplitudes at 236.3 nm for the IRB determination and at 260.0 nm for the HCT determination, respectively. The proposed method was validated by using the recovery studies, intra-day and inter-day assays and standard addition technique.
Result and Discussion: This study aims to apply a rapid and powerful signal processing method to the simultaneous quantification of IRB and HCT in their synthetic mixtures and tablets. As can be seen, the UV spectra of two drugs overlapped strongly in same spectral region. Direct conventional absorbance measurements do not give expected results for the IRB-HCT tablet analysis mainly due to the spectral interference. However, in order to reach a reasonable spectral analysis outcome, we focused mainly on the application of the ratio-derivative spectra treatment to the quantitative resolution of IRB-HCT mixtures without having to a separation procedure.

References

  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Maurer H. H. (1994) Toxicological analysis of drugs: GC-MS screening and confirmation. Acta Medicinæ Legalis, XLIV, 489-492.
  • 12. Daubechies I. (1992) Ten Lectures on Wavelets, Society for Industrial and Applied Mathematics, Philadelphia, 1-357.
  • 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. 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. 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. Albero I., Rodenas V., Garcia S., Sanchez C. (2002) Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry. J. Pharmaceut. Biomed., 29(1-2), 299-305.
  • 17. El-Yazbi A., Hammud H., Sonji M. (2007) Analysis of eprosartan-hydrochlorothiazide and irbesartan -hydrochlorothiazide binary mixtures by derivative spectrophotometry. Int. J. App. Chem., 3(1), 1-12.
  • 18. Joseph J., Brault S., Boyer C., Langlois M., Cabrero L., Dubost J. (2003) Simultaneous determination of irbesartan and hydrochlorothiazide in tablets by derivative spectrophotometry. Anal. Lett., 36(11), 2485-2495.
  • 19. Zhu J., You S., Meng X. (2003) Determination of irbesartan and hydrochlorothiazide in compound irbesartan tablets by HPLC. Zhongguo Yiyao Gongye Zazhi, 34(11), 567-569.
  • 20. Tutunji L. F., Tutunji M. F., Alzoubi M. I., Khabbas M. H., Arida A. I. (2009) Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma using HPLC coupled with tandem mass spectrometry:Application to bioequivalence studies. J. Pharmaceut. Biomed., 51(4), 985-990.
  • 21. Alanazi A. M., Abdelhameed A. S., Khalil N.Y., Khan A. A., Darwish I. A. (2014) HPLC method with monolithic column for simultaneous determination of irbesartan and hydrochlorothiazide in tablets. Acta Pharm., 64, 187-198.
  • 22. Kalyani G., Adjuad B. (2019) Stability indicating assay and estimation of irbesartan by first order uv derivative spectrophotometry. International Journal of Pharmaceutical Sciences and Research, 23, 3817-3821.
There are 21 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences
Journal Section Research Article
Authors

Özgür Üstündağ 0000-0001-9611-4210

Erdal Dinç 0000-0001-6326-1441

Publication Date September 30, 2020
Submission Date September 25, 2020
Acceptance Date September 30, 2020
Published in Issue Year 2020

Cite

APA Üstündağ, Ö., & Dinç, E. (2020). SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE. Journal of Faculty of Pharmacy of Ankara University, 44(3), 506-516. https://doi.org/10.33483/jfpau.799897
AMA Üstündağ Ö, Dinç E. SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE. Ankara Ecz. Fak. Derg. September 2020;44(3):506-516. doi:10.33483/jfpau.799897
Chicago Üstündağ, Özgür, and Erdal Dinç. “SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE”. Journal of Faculty of Pharmacy of Ankara University 44, no. 3 (September 2020): 506-16. https://doi.org/10.33483/jfpau.799897.
EndNote Üstündağ Ö, Dinç E (September 1, 2020) SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE. Journal of Faculty of Pharmacy of Ankara University 44 3 506–516.
IEEE Ö. Üstündağ and E. Dinç, “SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE”, Ankara Ecz. Fak. Derg., vol. 44, no. 3, pp. 506–516, 2020, doi: 10.33483/jfpau.799897.
ISNAD Üstündağ, Özgür - Dinç, Erdal. “SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE”. Journal of Faculty of Pharmacy of Ankara University 44/3 (September 2020), 506-516. https://doi.org/10.33483/jfpau.799897.
JAMA Üstündağ Ö, Dinç E. SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE. Ankara Ecz. Fak. Derg. 2020;44:506–516.
MLA Üstündağ, Özgür and Erdal Dinç. “SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE”. Journal of Faculty of Pharmacy of Ankara University, vol. 44, no. 3, 2020, pp. 506-1, doi:10.33483/jfpau.799897.
Vancouver Üstündağ Ö, Dinç E. SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE. Ankara Ecz. Fak. Derg. 2020;44(3):506-1.

Kapsam ve Amaç

Ankara Üniversitesi Eczacılık Fakültesi Dergisi, açık erişim, hakemli bir dergi olup Türkçe veya İngilizce olarak farmasötik bilimler alanındaki önemli gelişmeleri içeren orijinal araştırmalar, derlemeler ve kısa bildiriler için uluslararası bir yayım ortamıdır. Bilimsel toplantılarda sunulan bildiriler supleman özel sayısı olarak dergide yayımlanabilir. Ayrıca, tüm farmasötik alandaki gelecek ve önceki ulusal ve uluslararası bilimsel toplantılar ile sosyal aktiviteleri içerir.