Araştırma Makalesi
Yıl 2025,
Cilt: 20 Sayı: 1, 1 - 9, 25.05.2025
Öz
Artificial neural network (ANN) is a useful tool in chemometrics to model the complex relationship in spectral data resulting in overlapping spectra, spectral interferences, non-linearity, and deviations from Lambert-Beer law. In this work, a new application of ANN was proposed for the simultaneous spectrophotometric quantification of amlodipine (AML) and rosuvastatin (ROS) in tablets despite their overlapping spectra. The relationship between the actual concentrations and absorption data of binary calibration samples was modeled by ANN. The validity of the method was proved by analyzing AML and ROS in their laboratory-made mixtures, intra and, inter-day samples, as well as standard addition samples. The developed method was then applied to the simultaneous quantitation of AML and ROS in commercial tablets and a good agreement was reported between label claim assay results.
Anahtar Kelimeler
Chemometrics Artificial neural network Amlodipine Rosuvastatin Tablet analysis
Kaynakça
- M. Ashfaq, T. Akhtar, G. Mustafa, M. Danish, S.N. Razzaq, M.F. Nazar, “Simultaneous estimation of rosuvastatin and amlodipine in pharmaceutical formulations using stability indicating HPLC method”, Brazilian Journal of Pharmaceutical Sciences, 50(3), 629-638, 2014.
- Y. J. Hong, M.H. Jeong, K.H. Cho, “Impact of renal function on changes of plaque characteristics in non-intervened coronary segments after rosuvastatin treatment in patients with angina pectoris and hypertension”, International Journal of Cardiology, 187, 286-287, 2015.
- M, Haria, A. Wagstaff. “Amlodipine. A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease”, Drugs, 50, 560-586, 1995.
- A.G. Olsson, F. Mctaggart, A. Raza, “Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor”, Cardiovascular Drug Reviews, 20, 303-328, 2002.
- S.J. Seong, B. Ohk, W.Y. Kang, Mi-Ri Gwon, B.K. Kim, S. Cho, D.H. Yang, H.W. Lee, Y-R. Yoon, “Pharmacokinetic Drug Interactions between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers”, Advances in Therapy. 36, 1642-1656, 2019.
- O.C. Lastra, I.G. Lemus, H.J. Sánchez, R.F. Pérez, “Development and validation of an UV derivative spectrophotometric determination of Losartan potassium in tablets” Journal of Pharmaceutical and Biomedical Analysis, 33, 175-180, 2003.
- S. Tatar, S. Saglik, “Comparison of UV- and second derivative-spectrophotometric and LC methods for the determination of valsartan in pharmaceutical formulation” Journal of Pharmaceutical and Biomedical Analysis, 30, 371-375, 2002.
- V.K. Redasani, P.R. Patel, D.Y. Marathe, S.R. Chaudhari, A.A. Shirkhedkar, S.J. Surana, “A review on derivative UV-spectrophotometry analysis of drugs in pharmaceutical formulations and biological samples review”, Journal of the Chilean Chemical Society, 63(3), 4126-4134, 2018.
- M.A. Mukthinuthalapati, J.S.P. Kumar, “Simultaneous derivative spectrophotometric determination of candesartan cilexetil and hydrochlorothiazide” Pharmaceutical Methods, 6, 148-151, 2015.
- T.S. Belal, H.G. Daabeesb, M.M. Abdel-Khalekb, M.S. Mahrousb, M.M. Khamisb, “New simple spectrophotometric method for determination of the binary mixtures (atorvastatin calcium and ezetimibe; candesartan cilexetil and hydrochlorothiazide) in tablets” Journal of Pharmaceutical Analysis, 3(2), 118-126, 2013.
- E. Dinç, D. Baleanu, “Simultaneous spectrophotometric determination of levamisole and oxyclozanide in bolus by the bivariate and multivariate linear regression calibration” Revista de Chimie, 64(3), 233-237, 2013.
- Ö. Üstündağ, E. Dinç, “Simultaneous resolution of a binary mixture of captopril and hydrochlorothiazide in tablets by bivariate and multivariate spectral calibrations” Die Pharmazie, 58(9), 623-628, 2003.
- G. Ioele, M. De Luca, E. Dinç, F. Oliverio, G. Ragno, “Artificial Neural Network Combined with Principal Component Analysis for Resolution of Complex Pharmaceutical Formulations”, Chemical and Pharmaceutical Bulletin, 59 (1), 35-40, 2011.
- E. Dinç. N. Sen Koktas, D. Baleanu, “An Application of Principal Component Analysis Artificial Neural Network for the Simultaneous Quantitative Analysis of a Binary Mixture System” Revista De Chimie, 60 (7), 662-665, 2009.
- E. Dinç, Ö. Üstündağ, “Quantitative Analysis of Hydrochlorothiazide and Losartan Potassium in A Binary Mixture by Artificial Neural Network” FABAD Journal of Pharmaceutical Sciences, 35, 133-141, 2010.
- R. Magdy, A. Hemdan, N. Fares, M. Farouk, “Determination of amlodipine and atorvastatin mixture by different spectrophotometric methods with or without regression equations” Spectrochim. Acta A Mol. Biomol. Spectrosc., 210, 203-211, 2019.
- A. Hemdan, “Development and validation of different methods manipulating zero order and first order spectra for determination of the partially overlapped mixture benazepril and amlodipine: a comparative study” Spectrochim. Acta A Mol. Biomol. Spectrosc., 164, 52-60, 2016.
- T. A Wani, I. A Darwish, N. Y Khalil, “Novel microwell-based spectrophotometric assay for the determination of rosuvastatin calcium in its pharmaceutical formulations” Curr. Pharm. Anal., 9, 54-60, 2013.
- A.M. El-Kosasy, S.M. Tawakkol, M.F. Ayad, A.I. Sheta, “New methods for amlodipine and valsartan native spectrofluorimetric determination, with factors optimization study” Talanta, 143, 402-413, 2015.
- T.S. Belal, M.S. Mahrous, M.M. Abdel-Khalek, H.G. Daabees, M.M. Khamis, “Validated spectrofluorimetric determination of two pharmaceutical antihypertensive mixtures containing amlodipine besylate together with either candesartan cilexetil or telmisartan” Luminescence, 29, 893-900, 2014.
- R.I. El-Bagary, E.F. ElKady, A.M. Kadry, “Spectrofluorometric determination of certain antihyperlipidemic agents in bulk and pharmaceutical preparations” J. Spectr., 27, 83-92, 2012.
- K. Duraisamy, K. Jaganathan, “Method development and validation of HPLC tandem/mass spectrometry for quantification of perindopril arginine and amlodipine besylate combination in bulk and pharmaceutical formulations” Res. Pharm. Sci., 12, 307, 2017.
- H.T. Kumar, S.D. Sri, V.P.K. Rao, S.Y. Rao, “Validated RP-HPLC method for determination of rosuvastatin calcium in bulk and pharmaceutical formulation” Int. J. Pharm. Sci. Res., 6, 2913-2917, 2015.
- M.R. Rezk, K.A. Badr, “Quantification of amlodipine and atorvastatin in human plasma by UPLC–MS/MS method and its application to a bioequivalence study” Biomed. Chromatogr., 32, e4224, 2018.
- J. Zakrajšek, K. Bevc-Černilec, S. Bohanec, U. Urleb, “Optimization of UPLC method for simultaneous determination of rosuvastatin and rosuvastatin degradation products” Acta Chim. Slov., 64, 968-979, 2017.
- I. Rebech, C.A.R. Salamanca-Neto, J. Scremin, E.R. Sartori, “Simultaneous Voltammetric determination of amlodipine and atorvastatin on anodically pretreated boron-doped diamond electrode” Orbital: Electron. J. Chem., 9, 225-233, 2017.
- J.T. Moraes, A.P. Eisele, C.A. Salamanca-Neto, J. Scremin, E.R. Sartori, “Simultaneous voltammetric determination of antihypertensive drugs amlodipine and atenolol in pharmaceuticals using a cathodically pretreated boron-doped diamond electrode” J. Braz. Chem. Soc., 27, 1264-1272, 2016.
- M. Ashfaq, T. Akhtar, G. Mustafa, M. Danish, S. N. Razzaq, M. F. Nazar, “Simultaneous estimation of rosuvastatin and amlodipine in pharmaceutical formulations using stability indicating HPLC method” Brazilian Journal of Pharmaceutical Sciences, 50(3) 2014.
- D. Tajane, A.M. Raurale, P.D. Bharande, A.N. Mali, A.V. Gadkari, V.R. Bhosale, “Development and validation of an RP-HPLC-PDA method for simultaneous determination of rosuvastatin calcium and amlodipine besylate in pharmaceutical dosage form” J. Chem. Pharm. Res., 4, 2789-2794, 2012.
- A. Narapusetti, S.S. Bethanabhatla, A. Sockalingam, N. Repaka, V. Saritha, “Simultaneous determination of rosuvastatin and amlodipine in human plasma using tandem mass spectrometry: application to disposition kinetics” J. Adv. Res., 6, 931-940, 2015.
Yıl 2025,
Cilt: 20 Sayı: 1, 1 - 9, 25.05.2025
Öz
Kaynakça
- M. Ashfaq, T. Akhtar, G. Mustafa, M. Danish, S.N. Razzaq, M.F. Nazar, “Simultaneous estimation of rosuvastatin and amlodipine in pharmaceutical formulations using stability indicating HPLC method”, Brazilian Journal of Pharmaceutical Sciences, 50(3), 629-638, 2014.
- Y. J. Hong, M.H. Jeong, K.H. Cho, “Impact of renal function on changes of plaque characteristics in non-intervened coronary segments after rosuvastatin treatment in patients with angina pectoris and hypertension”, International Journal of Cardiology, 187, 286-287, 2015.
- M, Haria, A. Wagstaff. “Amlodipine. A reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease”, Drugs, 50, 560-586, 1995.
- A.G. Olsson, F. Mctaggart, A. Raza, “Rosuvastatin: a highly effective new HMG-CoA reductase inhibitor”, Cardiovascular Drug Reviews, 20, 303-328, 2002.
- S.J. Seong, B. Ohk, W.Y. Kang, Mi-Ri Gwon, B.K. Kim, S. Cho, D.H. Yang, H.W. Lee, Y-R. Yoon, “Pharmacokinetic Drug Interactions between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers”, Advances in Therapy. 36, 1642-1656, 2019.
- O.C. Lastra, I.G. Lemus, H.J. Sánchez, R.F. Pérez, “Development and validation of an UV derivative spectrophotometric determination of Losartan potassium in tablets” Journal of Pharmaceutical and Biomedical Analysis, 33, 175-180, 2003.
- S. Tatar, S. Saglik, “Comparison of UV- and second derivative-spectrophotometric and LC methods for the determination of valsartan in pharmaceutical formulation” Journal of Pharmaceutical and Biomedical Analysis, 30, 371-375, 2002.
- V.K. Redasani, P.R. Patel, D.Y. Marathe, S.R. Chaudhari, A.A. Shirkhedkar, S.J. Surana, “A review on derivative UV-spectrophotometry analysis of drugs in pharmaceutical formulations and biological samples review”, Journal of the Chilean Chemical Society, 63(3), 4126-4134, 2018.
- M.A. Mukthinuthalapati, J.S.P. Kumar, “Simultaneous derivative spectrophotometric determination of candesartan cilexetil and hydrochlorothiazide” Pharmaceutical Methods, 6, 148-151, 2015.
- T.S. Belal, H.G. Daabeesb, M.M. Abdel-Khalekb, M.S. Mahrousb, M.M. Khamisb, “New simple spectrophotometric method for determination of the binary mixtures (atorvastatin calcium and ezetimibe; candesartan cilexetil and hydrochlorothiazide) in tablets” Journal of Pharmaceutical Analysis, 3(2), 118-126, 2013.
- E. Dinç, D. Baleanu, “Simultaneous spectrophotometric determination of levamisole and oxyclozanide in bolus by the bivariate and multivariate linear regression calibration” Revista de Chimie, 64(3), 233-237, 2013.
- Ö. Üstündağ, E. Dinç, “Simultaneous resolution of a binary mixture of captopril and hydrochlorothiazide in tablets by bivariate and multivariate spectral calibrations” Die Pharmazie, 58(9), 623-628, 2003.
- G. Ioele, M. De Luca, E. Dinç, F. Oliverio, G. Ragno, “Artificial Neural Network Combined with Principal Component Analysis for Resolution of Complex Pharmaceutical Formulations”, Chemical and Pharmaceutical Bulletin, 59 (1), 35-40, 2011.
- E. Dinç. N. Sen Koktas, D. Baleanu, “An Application of Principal Component Analysis Artificial Neural Network for the Simultaneous Quantitative Analysis of a Binary Mixture System” Revista De Chimie, 60 (7), 662-665, 2009.
- E. Dinç, Ö. Üstündağ, “Quantitative Analysis of Hydrochlorothiazide and Losartan Potassium in A Binary Mixture by Artificial Neural Network” FABAD Journal of Pharmaceutical Sciences, 35, 133-141, 2010.
- R. Magdy, A. Hemdan, N. Fares, M. Farouk, “Determination of amlodipine and atorvastatin mixture by different spectrophotometric methods with or without regression equations” Spectrochim. Acta A Mol. Biomol. Spectrosc., 210, 203-211, 2019.
- A. Hemdan, “Development and validation of different methods manipulating zero order and first order spectra for determination of the partially overlapped mixture benazepril and amlodipine: a comparative study” Spectrochim. Acta A Mol. Biomol. Spectrosc., 164, 52-60, 2016.
- T. A Wani, I. A Darwish, N. Y Khalil, “Novel microwell-based spectrophotometric assay for the determination of rosuvastatin calcium in its pharmaceutical formulations” Curr. Pharm. Anal., 9, 54-60, 2013.
- A.M. El-Kosasy, S.M. Tawakkol, M.F. Ayad, A.I. Sheta, “New methods for amlodipine and valsartan native spectrofluorimetric determination, with factors optimization study” Talanta, 143, 402-413, 2015.
- T.S. Belal, M.S. Mahrous, M.M. Abdel-Khalek, H.G. Daabees, M.M. Khamis, “Validated spectrofluorimetric determination of two pharmaceutical antihypertensive mixtures containing amlodipine besylate together with either candesartan cilexetil or telmisartan” Luminescence, 29, 893-900, 2014.
- R.I. El-Bagary, E.F. ElKady, A.M. Kadry, “Spectrofluorometric determination of certain antihyperlipidemic agents in bulk and pharmaceutical preparations” J. Spectr., 27, 83-92, 2012.
- K. Duraisamy, K. Jaganathan, “Method development and validation of HPLC tandem/mass spectrometry for quantification of perindopril arginine and amlodipine besylate combination in bulk and pharmaceutical formulations” Res. Pharm. Sci., 12, 307, 2017.
- H.T. Kumar, S.D. Sri, V.P.K. Rao, S.Y. Rao, “Validated RP-HPLC method for determination of rosuvastatin calcium in bulk and pharmaceutical formulation” Int. J. Pharm. Sci. Res., 6, 2913-2917, 2015.
- M.R. Rezk, K.A. Badr, “Quantification of amlodipine and atorvastatin in human plasma by UPLC–MS/MS method and its application to a bioequivalence study” Biomed. Chromatogr., 32, e4224, 2018.
- J. Zakrajšek, K. Bevc-Černilec, S. Bohanec, U. Urleb, “Optimization of UPLC method for simultaneous determination of rosuvastatin and rosuvastatin degradation products” Acta Chim. Slov., 64, 968-979, 2017.
- I. Rebech, C.A.R. Salamanca-Neto, J. Scremin, E.R. Sartori, “Simultaneous Voltammetric determination of amlodipine and atorvastatin on anodically pretreated boron-doped diamond electrode” Orbital: Electron. J. Chem., 9, 225-233, 2017.
- J.T. Moraes, A.P. Eisele, C.A. Salamanca-Neto, J. Scremin, E.R. Sartori, “Simultaneous voltammetric determination of antihypertensive drugs amlodipine and atenolol in pharmaceuticals using a cathodically pretreated boron-doped diamond electrode” J. Braz. Chem. Soc., 27, 1264-1272, 2016.
- M. Ashfaq, T. Akhtar, G. Mustafa, M. Danish, S. N. Razzaq, M. F. Nazar, “Simultaneous estimation of rosuvastatin and amlodipine in pharmaceutical formulations using stability indicating HPLC method” Brazilian Journal of Pharmaceutical Sciences, 50(3) 2014.
- D. Tajane, A.M. Raurale, P.D. Bharande, A.N. Mali, A.V. Gadkari, V.R. Bhosale, “Development and validation of an RP-HPLC-PDA method for simultaneous determination of rosuvastatin calcium and amlodipine besylate in pharmaceutical dosage form” J. Chem. Pharm. Res., 4, 2789-2794, 2012.
- A. Narapusetti, S.S. Bethanabhatla, A. Sockalingam, N. Repaka, V. Saritha, “Simultaneous determination of rosuvastatin and amlodipine in human plasma using tandem mass spectrometry: application to disposition kinetics” J. Adv. Res., 6, 931-940, 2015.
Toplam 30 adet kaynakça vardır.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Analitik Spektrometri |
| Bölüm | Makaleler |
| Yazarlar | |
| Yayımlanma Tarihi | 25 Mayıs 2025 |
| Gönderilme Tarihi | 16 Temmuz 2024 |
| Kabul Tarihi | 3 Ocak 2025 |
| Yayımlandığı Sayı | Yıl 2025 Cilt: 20 Sayı: 1 |
