Abstract
In this study, simultaneous spectrophotometric determination of atorvasatin and ezetimibe active substances used in the treatment of hyperlipidaemia was performed. In the study, the partial least squares method, which is one of the chemometric programmes, was calculated by taking into account the ultra-violet visible field spectroscopy data. The recovery values and relative Standard deviation values expressed statistically by Partial Least Squares (PLS), a chemometric method, are analytically appropriate. It is seen that the regression coefficient is close to 1 in the relationship between realized and predicted values. Analytical parameters were calculated to validate the method. The suitability of the method was tested before proceeding to the drug samples obtained from the pharmacy. This process was tested by analysis of variance. The calculated F value should be lower than the F baseline value or the F theoretical value. The Pearson correlation coefficient (i.e. P value) must also be greater than 0.05. Ensure that the method is consistent with the calculated values. The method applied in this study can also be applied to complex two-component drug mixtures.
Ethical Statement
Bu çalışmada, “Yükseköğretim Kurumları Bilimsel Araştırma ve Yayın Etiği Yönergesi” kapsamındaki tüm kurallara uyduklarını, ilgili yönergenin “Bilimsel Araştırma ve Yayın Etiğine Aykırı Eylemler” olarak belirtilen başlığı altındaki eylemlerden hiçbirini gerçekleştirmediğimizi taahhüt ederiz.
Supporting Institution
Bu araştırma, Süleyman Demirel Üniversitesi Bilimsel Araştırma Projeleri Koordinasyon Birimi Koordinatörlüğü’nce desteklenmiştir (Proje Numarası: FYL-2019-7351).
Project Number
FYL-2019-7351
References
- V. Narla, M.J. Blaha, R.S. Blumenthal, E. D. Michos, “The JUPITER and AURORA clinical trials for rosuvastatin in special primary prevention populations: perspectives, outcomes, and consequences,” Vasc. Health Risk Manag. vol. 5, pp.1033-1042, 2009.
- İ. Arıkan, S. Metintaş, C. Kalyoncu, Z. Yıldız, “The Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL) Scale: a validity and reliability study,” Arch. Turk. Soc. Cardiol., vol. 37, pp. 35-40, 2009.
- S. Civek, M. Akman, “Dünya ve Türkiye’de kardiyovasküler hastalıkların sıklığı ve riskin değerlendirilmesi,” The Journal of Turkish Family Physician, c.13, sayı 1, ss. 21-28, 2008.
- N. Jain, R. Jain, H. Swami, D. K. Jain, “RP-HPLC Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Bulk Drug and its Combined Dosage Form,” Asian J. Research Chem. vol.1, no.1, pp. 29-31, 2008.
- M. Rahman, G. Parveen, N.K. Nyola, S. Khan, S.Talegaonkar, M. Shahar yar, R.K. Khar, “Simultaneus Estimation of Simvastatin and Ezetimibe in Pharmaceutical Tablet Dosage Forms by RP-HPLC: A Reviev,” International Journal of Pharma Research and Development, vol. 2, no. 9, pp. 56-62, 2010.
- B. P. Kumar, S. Vidyadhara, T.E.G.K. Murthy, B.V. Rao, V. Nikhila, “A Novel Reverse Phase Liquid Chromatographic Method Development and Vlidation for the Simultaneous Estimation of Atorvastatin, Ezetimibe and Fenofibrate in Bulk and Tablet Dosage Form,” International Journal of Pharmaceutical Sciences and Research, vol. 7, no.10, pp. 4145-4151, 2016.
- R. Cistla, V.S.S.K. Tata, Y.V. Kashyap, D. Chandrasekar, P.V. Diwan, “Development and validation of a reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms,” Journal of Pharmaceutical and Biomedical Analysis, vol. 39, pp. 517–522, 2005.
- P. Kancherla,V. Velpuri, P. Alegete, S.S. Albaseer, M. Khagga, P. Das, “LC-MS/MS characterization of the forced degradation products of ezetimibe: Development and validation of a stability-indicating UPLC method,” Journal of Taibah University For Science, Vol. 10, no.1, pp.148-160, 2016.
- S. Chitravathi, S. Reddy, B.E.K. Swamy, “Electrochemical determination of ezetimibe by MgO nanoflakes-modified carbon paste electrode,” Journal of Electroanalytical Chemistry, Vol. 764, pp.1–6, 2016.
- N. Jain, R. Jain, H. Swami, S. Padey, D.K. Jain, “Spectrophotometric method for simultaneous estimation of simvastatin and ezetimibe in bulk drug and its combined dosage form,” International Journal of Pharmacy and Pharmaceutical Sciences, vol. 1, no.1, pp. 170-175, 2009.
- U.P. Patil, S.V. Gandhi, M.R. Sengar, V.S. Rajmane, “A validated densitometric method for analysis of telmisartan and atorvastatin calcium in fixed döşe combination,” J. Chil. Chem. Soc., pp. 94-96, 2010.
- S.S. Sonawane, A.A. Shirkhedkar, R.A. Fursule, S.J. Surana, “Simultaneous spectrophotometric estimation of atorvastatin calcium and amlodipine in tablets,” Indian J. Pharm. Sci, vol.69, no.5, pp. 683, 2007.
- A. Shravya, R.S. Chandan, B.M. Grurupadayya, M. Sireesha, “Spectrophotometric determination of atorvastatin and amlodipin using 2,4-DNP in bulk in pharmaceutical dosage form,” vol.24, no.1, pp. 1046-1056, 2010.
- A. Güven, “Hiperkolesterolemi oluşturulmuş tavşanlarda kefirin total kolesterol, trigliserit, HDL-kolesterol, LDL-kolesterol ve lipit peroksidasyonu üzerine etkisi,” Kafkas Üniversitesi Veteriner Fakültesi Dergisi, c. 2, sayı 11, ss. 127-131, 2005.
- A Minitab 17 Statistical Programme. Erişim Tarihi: 16.05.2023. [Online]. http://www.inovadanismanlik.com.tr
- D. Sharma, R. Singh, V. Garg “Development andvalidation of stabilityindicating UV spectro-photometric method for the estimation of benzydamine hydrochloride in bulkand in pharmaceutical dosage form: a novel analytical technique for conducting in-vitroquality control tests,” International Journal Of Pharmaceutical Sciences And Research, vol. 9, no.2, pp. 678-686, 2017.
- J. Miao, B. Forget, K. Smith, “Predicting Correlation Coefficients for Monte Carlo Eigen value Simulations With Multitype Branching Process,” Annals of Nuclear Energy, vol.11, pp. 207-321, 2018.
- E. Dinç, “Kemometrik İşlem ve Yöntemlerin Analitik Kimyadaki Tipik Uygulamaları,” Uygulamalı Kemometri Yaz Okulu Notları, ss.13-17.
- A. Porfire, D. Muntean, M. Achim, L. Vlase, I. Tomuta, “Simultaneous Quantification of Simvastatin and Excipients in Liposomes Using Near Spectroscopy and Chemometry,” Journal of Pharmaceutical and Biomedical Analysis, vol. 107, pp. 40-49, 2015.
- I. Tarhan, A. A. I. H. Kara, “Quantitative Determination of Free Fatty Acids in Extra Virgin Olive Oils by Multivariate Methods and Fourier Transform Infrared Spectroscopy Considering Different Absorption Modes,” International Journal of Food Properties, vol.20, no.S1, pp. 790-797, 2017.
Abstract
Bu çalışmada, kolestrol yüksekliği tedavisinde kullanılan ilaç etken maddelerinde atorvasatin ve ezetimibin miktar tayinleri kemometrik programlardan olan kısmi en küçük kareler metodu ile ultra viyole görünür alan spektroskopisi verileri öz önüne alınarak hesaplanmıştır. Kısmi en küçük kareler (PLS) yöntemi ile hesaplanan değerlere bakıldığında geri kazanım değerleri oldukça yüksek, bağıl standart sapma değerleri de yeterince küçük değerler olarak elde edilmiştir. Gerçek ve tahmini yani hesaplanan değerler arasındaki ilişkide de regresyon katsayıları bir değerine yakın bulunmuştur. Yöntemin geçerliliği için analitik parametreler hesaplanmıştır. Ticari ilaç tabletlerine geçmeden önce uygulanan yöntemlerin uygunluğu da kontrol edilmiştir. Bu işlem için ANOVA testi yapılmıştır. F hesaplanan değerleri F ölçüt ya da F teorik değerlerinden düşük olmalıdır. P değeri olan pearson korelasyon katsayısının da 0,05 değerinden büyük olması gerekmektedir. Hesaplanan değerler ile yöntemin uygun olduğuna karar verilmiştir. Bu çalışmada uygulanan yöntemler, iki bileşenli karmaşık ilaç karışımlarına uygulanabilmektedir.
Supporting Institution
Süleyman Demirel Üniversitesi Bilimsel Araştırma Projeleri Koordinasyon Birimi Koordinatörlüğü (Proje Numarası: FYL-2019-7351)
Project Number
FYL-2019-7351
Thanks
Bu araştırma, Süleyman Demirel Üniversitesi Bilimsel Araştırma Projeleri Koordinasyon Birimi Koordinatörlüğü’nce desteklenmiştir (Proje Numarası: FYL-2019-7351).
References
- V. Narla, M.J. Blaha, R.S. Blumenthal, E. D. Michos, “The JUPITER and AURORA clinical trials for rosuvastatin in special primary prevention populations: perspectives, outcomes, and consequences,” Vasc. Health Risk Manag. vol. 5, pp.1033-1042, 2009.
- İ. Arıkan, S. Metintaş, C. Kalyoncu, Z. Yıldız, “The Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL) Scale: a validity and reliability study,” Arch. Turk. Soc. Cardiol., vol. 37, pp. 35-40, 2009.
- S. Civek, M. Akman, “Dünya ve Türkiye’de kardiyovasküler hastalıkların sıklığı ve riskin değerlendirilmesi,” The Journal of Turkish Family Physician, c.13, sayı 1, ss. 21-28, 2008.
- N. Jain, R. Jain, H. Swami, D. K. Jain, “RP-HPLC Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Bulk Drug and its Combined Dosage Form,” Asian J. Research Chem. vol.1, no.1, pp. 29-31, 2008.
- M. Rahman, G. Parveen, N.K. Nyola, S. Khan, S.Talegaonkar, M. Shahar yar, R.K. Khar, “Simultaneus Estimation of Simvastatin and Ezetimibe in Pharmaceutical Tablet Dosage Forms by RP-HPLC: A Reviev,” International Journal of Pharma Research and Development, vol. 2, no. 9, pp. 56-62, 2010.
- B. P. Kumar, S. Vidyadhara, T.E.G.K. Murthy, B.V. Rao, V. Nikhila, “A Novel Reverse Phase Liquid Chromatographic Method Development and Vlidation for the Simultaneous Estimation of Atorvastatin, Ezetimibe and Fenofibrate in Bulk and Tablet Dosage Form,” International Journal of Pharmaceutical Sciences and Research, vol. 7, no.10, pp. 4145-4151, 2016.
- R. Cistla, V.S.S.K. Tata, Y.V. Kashyap, D. Chandrasekar, P.V. Diwan, “Development and validation of a reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms,” Journal of Pharmaceutical and Biomedical Analysis, vol. 39, pp. 517–522, 2005.
- P. Kancherla,V. Velpuri, P. Alegete, S.S. Albaseer, M. Khagga, P. Das, “LC-MS/MS characterization of the forced degradation products of ezetimibe: Development and validation of a stability-indicating UPLC method,” Journal of Taibah University For Science, Vol. 10, no.1, pp.148-160, 2016.
- S. Chitravathi, S. Reddy, B.E.K. Swamy, “Electrochemical determination of ezetimibe by MgO nanoflakes-modified carbon paste electrode,” Journal of Electroanalytical Chemistry, Vol. 764, pp.1–6, 2016.
- N. Jain, R. Jain, H. Swami, S. Padey, D.K. Jain, “Spectrophotometric method for simultaneous estimation of simvastatin and ezetimibe in bulk drug and its combined dosage form,” International Journal of Pharmacy and Pharmaceutical Sciences, vol. 1, no.1, pp. 170-175, 2009.
- U.P. Patil, S.V. Gandhi, M.R. Sengar, V.S. Rajmane, “A validated densitometric method for analysis of telmisartan and atorvastatin calcium in fixed döşe combination,” J. Chil. Chem. Soc., pp. 94-96, 2010.
- S.S. Sonawane, A.A. Shirkhedkar, R.A. Fursule, S.J. Surana, “Simultaneous spectrophotometric estimation of atorvastatin calcium and amlodipine in tablets,” Indian J. Pharm. Sci, vol.69, no.5, pp. 683, 2007.
- A. Shravya, R.S. Chandan, B.M. Grurupadayya, M. Sireesha, “Spectrophotometric determination of atorvastatin and amlodipin using 2,4-DNP in bulk in pharmaceutical dosage form,” vol.24, no.1, pp. 1046-1056, 2010.
- A. Güven, “Hiperkolesterolemi oluşturulmuş tavşanlarda kefirin total kolesterol, trigliserit, HDL-kolesterol, LDL-kolesterol ve lipit peroksidasyonu üzerine etkisi,” Kafkas Üniversitesi Veteriner Fakültesi Dergisi, c. 2, sayı 11, ss. 127-131, 2005.
- A Minitab 17 Statistical Programme. Erişim Tarihi: 16.05.2023. [Online]. http://www.inovadanismanlik.com.tr
- D. Sharma, R. Singh, V. Garg “Development andvalidation of stabilityindicating UV spectro-photometric method for the estimation of benzydamine hydrochloride in bulkand in pharmaceutical dosage form: a novel analytical technique for conducting in-vitroquality control tests,” International Journal Of Pharmaceutical Sciences And Research, vol. 9, no.2, pp. 678-686, 2017.
- J. Miao, B. Forget, K. Smith, “Predicting Correlation Coefficients for Monte Carlo Eigen value Simulations With Multitype Branching Process,” Annals of Nuclear Energy, vol.11, pp. 207-321, 2018.
- E. Dinç, “Kemometrik İşlem ve Yöntemlerin Analitik Kimyadaki Tipik Uygulamaları,” Uygulamalı Kemometri Yaz Okulu Notları, ss.13-17.
- A. Porfire, D. Muntean, M. Achim, L. Vlase, I. Tomuta, “Simultaneous Quantification of Simvastatin and Excipients in Liposomes Using Near Spectroscopy and Chemometry,” Journal of Pharmaceutical and Biomedical Analysis, vol. 107, pp. 40-49, 2015.
- I. Tarhan, A. A. I. H. Kara, “Quantitative Determination of Free Fatty Acids in Extra Virgin Olive Oils by Multivariate Methods and Fourier Transform Infrared Spectroscopy Considering Different Absorption Modes,” International Journal of Food Properties, vol.20, no.S1, pp. 790-797, 2017.
Details
| Primary Language | Turkish |
|---|---|
| Subjects | Analytical Spectrometry |
| Journal Section | Research Article |
| Authors | |
| Project Number | FYL-2019-7351 |
| Submission Date | May 17, 2023 |
| Early Pub Date | April 1, 2024 |
| Publication Date | June 10, 2024 |
| Published in Issue | Year 2024 Volume: 13 Issue: 1 |