Analysis of the binary mixtures of amlodipine and atorvastatin by chemometric-spectophotometric method
Year 2025,
Volume: 13 Issue: 1, 2 - 7, 27.06.2025
Güzide Pekcan
,
Tuğba Karaca Erol
,
Hayrettin Bulum
Abstract
In this study, the simultaneous quantification of amlodipine and atorvastatin in pharmaceutical preparations was successfully accomplished without the need for a separation process by using chemometric calibration methods (principal component analysis method (PCA), principal component regression method (PCR), and partial least squares method (PLS). Additionally, chemometric evaluation was performed on the data obtained from UV visible field spectroscopy methods. 16 mixes containing the chemicals atorvastatin and amlodipine were created as a calibration (concentration) set to assess the validity of the designated chemometric procedures. The calibration set's absorption spectrum was captured between 200 and 500 nm. The link between the calibration set and the absorption data collected in the 215–355 nm region was used to produce three chemometric calibrations. Amlodipine and atorvastatin synthetic mixtures were analyzed to assess the validity of the PCA, PCR, and PLS approaches. The percentage (%) recovery average for atorvastatin and amlodipine was determined for both the drug sample and the synthetic mixture using the approach we used. It was discovered that the computed values were fairly high.The methodologies were controlled, and the ANOVA test was run using the results of the PLS and PCR calibration techniques. The enhanced technique might be suggested for the examination of medication samples containing atorvastatin and amlodipine since it is among the most sensitive, accurate, and repeatable techniques available.
Supporting Institution
Suleyman Demirel University
Project Number
FYL-2021-8323
Thanks
This research work has been supported by research grants from Suleyman Demirel University Scientific Research Project FYL-2021-8323.
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Year 2025,
Volume: 13 Issue: 1, 2 - 7, 27.06.2025
Güzide Pekcan
,
Tuğba Karaca Erol
,
Hayrettin Bulum
Project Number
FYL-2021-8323
References
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İlaç Değişimleri ile Hedef Tedavi Değerlerine Ulaşma Oranlarının İncelenmesi”. Sağlık Bakanlığı Şişli Etfal
Eğitim ve Araştırma Hastanesi Aile Hekimliği Koordinatörlüğü, Uzmanlık Tezi, İstanbul, 2007, pp.98.
- [2]. Yılmaz N., “Amlodipin ve Rosuvastatin Etkin Maddelerinin Farmasötik Preparatlarda Kare Dalga
Voltametri Yöntemi ile Aynı Anda Miktar Tayini”. Atatürk Üniversitesi Sağlık Bilimleri Enstitüsü, Yüksek Lisans
Tezi, Erzurum, 2018, pp. 2-3.
- [3]. Tomikj M., Božinovska, Anevska-Stojanovska N., Lazova J., Acevska J., Brezovska K., Tonich-Ribarska J.,
Nakov N., “Sustainable and white HPLC method for simultaneous determination of amlodipine and
atorvastatin in film-coated tablet”,Green Analytical Chemistry, 8, 100103.
- [4]. Reid I.O.A., Mohamed M.E., “Chemometric Simultaneous Determination of Atorvastatin and Amlodipine
in Bulk and Tablets”, International Journal Pharmacy and Chemistry, 5(4), (2019), 42-47.
- [5]. Mansour F.R, “A New Innovative Spectrophotometric Method For The Simultaneous Determination of
Sofosbuvir and Ledipasvir”. Spectrochimica Acta Part A:Molecular and Biomolecular Spectroscopy 18(188),
(2018), 626-632.
- [6]. Dinç E., Baleanu D., “Spectrophotometric Quantitative Determination of Cilazapril and
Hydrochlorothiazide in Tablets By Chemometric Methods”. J. Pharmaceut. Biomed, 30, (2002), 715-723.
- [7]. Kenneth R, Chemometrics: A practical Guide. John Wiley & Sons. Inc., New York, 1997.
- [8]. “Minitab 17 Statistical Programme” http://www.inovadanismanlik.com.tr (06.11.2023).
- [9]. Dinç E., , “Kemometrik İşlem ve Yöntemlerin Analitik Kimyadaki Tipik Uygulamaları”, Uygulamalı
Kemometri Yaz Okulu Notları, 2009, pp. 13-17.
- [10]. Dinç E., Baleanu D., “ Spectrophotometric quantitative determination of cilazapril and
hydrochlorothiazide in tablets by chemometric methods” Journal of pharmaceutical and biomedical
analysis, 30, (2002), 715-723.
- [11]. Dinç E., ,Özdemir, A., Baleanu, D., “Comparative study of the continuous wavelent transform, derivative
and partial least squares methods applied to the overlapping spectra for the simultaneous quantitative
resolution of ascorbic acid and asetilsalicylic acid in effervescent tablets, Journal of pharmaceutical and
biomedical analysis, 37, (2005), 715-723.
- [12]. Ustündağ, O., & Dinç, E., “Simultaneous resolution of a binary mixture of captopril and
hydrochlorothiazide in tablets by bivariate and multivariate spectral calibrations”. Die Pharmazie, 58 (9),
(2003), 623-8 .
- [13]. Dinç, E., Ustündağ, O., & Baleanu, D. (2010). “Simultaneous chemometric determination of pyridoxine
hydrochloride and isoniazid in tablets by multivariate regression methods“.. Drug testing and analysis, 2
(8), (2010), 383-387.
- [14]. Porfire A, Muntean D, Achim M, Vlase L, Tomuta, I, “Simultaneous Quantification of Simvastatin and
Excipients in Liposomes Using Near Infrared Spectroscopy and Chemometry”. Journal of Pharmaceutical
and Biomedical Analysis 107, (2015), 40-49.
- [15]. Tarhan I, Kara AAIH, “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 (2017), 1-8.
- [16]. Abbai N, Parameswari SA, “Stability Indicating RP-HPLC Method Development and Validation for
Simultaneous Estimation od Salbutamol and Beclomethasone in Bulk and Tablet Dosage Form”, IJPSR 9(5),
(2009), 1980-1988.
- [17]. Aravind D, Kamarapu SK, “Method Development and Validation of RP-HPLC Method for
Simultaneous Estimation of Clidinium Bromide, Chlordiazepoxide and Dicylomine Hydrochloride in Bulk and
Combined Tablet Dosage Forms”, IJPBS 3(3), (2013), 152-161.
- [18]. Deshpande P, Mandawad V, “Development and Validation of Stability Indicating HPTLC Method for
Determination of Azelastine Hydrochloride as Bulk Drug and in Pharmaceutical Liquid Dosage Form”, IAJPS
05(06), (2018), 5107-5113.
- [19]. Bilgili AV, Çullu MA, Aydemir S, “Tuzdan Etkilenmiş Toprakların Yakın Kızılötesi Yansıma
Spektroradyometre ve Elektromanyetik Indüksiyon Tekniği Yardımıyla Karakterize Edilebilme Potansiyelinin
Araştırılması”. Harran Tarım ve Gıda Bilimleri Dergisi 18(1), (2014), 32-45.
- [20]. Shrivastava A, Gupta VB, “Methods For The Determination of Limit of Detection and Limit of
Quantitation of The Analytical Methods”. Chronicles of Young Scientist 2(1), (2011), 21-25.
- [21]. Armbruster DA, Pty T, “Limit of Blank, Limit of Detection and Limit of Quantitation”. Clin. Niochem Rev.
29, (2008), 49-52