Farmasötik Formülasyonlardaki İkili İlaç Bileşenlerinin Eş Zamanlı Olarak Kemometrik Metotlarla Tayini

Year 2020, , 1171 - 1179, 01.06.2020

Güzide Pekcan Ertokuş , Mine Bineci Doğan

https://doi.org/10.21597/jist.664254

Cited By: 1

Abstract

Farmasötik formülasyonlardaki parasetamol ve amoksisilin miktarlarının spektrofotometrik olarak eş zamanlı tayini yapılmıştır. Çok değişkenli kalibrasyon tekniklerinden temel bileşen regresyonu (TBR) ve kısmi en küçük kareler yöntemi (KEKK) kullanılmıştır. Spektrofotometrik-kemometrik metotlar kullanılarak, hem laboratuvarda hazırlanan sentetik karışımların hem de ilaç tabletlerinin hiçbir ön ayırma yapılmadan analizi sağlanmıştır. Sentetik karışımlardaki her aktif madde için kalibrasyon eğrilerinin doğrusallığı, konsantrasyon aralıklarının uygun olduğu gözlenmiştir (r2> 0,9997). İki yöntemin doğruluğu ve tekrarlanabilirliği incelendiğinde yüksek geri kazanım ve düşük standart sapma değerleri elde edilmiştir. Yüksek geri kazanım ve düşük standart sapma değerleri, bu çalışmada ilaç tablet analizleri konusunda bizi cesaretlendirmiştir. Önerilen metotlar, farmasötik örneklerdeki aktif bileşenlerin tayininin başarıyla uygulanması yönünden oldukça yüksek kesinlik ve duyarlılığa sahiptir.

Keywords

Parasetamol, Amoksisilin, PLS, PCR

Simultaneous Determination of Binary Drug Components in Pharmaceutical Formulations with Chemometric Methods

Abstract

A synchronous definition of paracetamol and amoxicillin quantities in pharmaceutical formulations was performed using spectrophotometric methods. Principal component regression (PCR) and partial least squares regression (PLS) were used as multivariate calibration techniques. Spectrophotometric-chemometric methods were used for the simultaneous quantification of paracetamol and amoxicillin in the laboratory prepared mixtures and in the drug tablets without any requirements for a prior separation. The linearity of the calibration curves for each active substance in the synthetic mixtures demonstrated that concentration ranges were appropriate (r2>0.9997). The investigation of the accuracy and repeatability of the two methods resulted in high recovery rates and lower standard deviation values. Achieving high recovery and low standard deviation values, this study encouraged us to proceed further in pharmaceutical assay. The recommended methods are highly sensitive and precise as these methods have been successfully applied to quantify active substances in pharmaceutical samples.

Keywords

Paracetamol, Amoxicillin, PLS, PCR

References

• Abbai N, Parameswari SA, 2009. Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation od Salbutamol and Beclomethasone in Bulk and Tablet Dosage Form. IJPSR 9(5): 1980-1988.
• Aktaş AH, Sarıdağ AM, 2017. Liquid Chromatographic-Chemometric Techniques For The Simultaneous HPLC Determination of Lansoprazole, Amoxicillin and Clarithromycin in Commercial Preparation. Journal of Chromatographic Science 1-7.
• Aktaş AH, Kitiş F, 2014. Spectrophotometric Simultaneous Determination Of Caffeine And Paracetamol In Commercial Pharmaceutical By Principal Component Regression, Partial Least Squares And Artificial Neural Networks Chemometric Methods. Croatica Chemica Acta 87(1): 69-74.
• Aktaş AH, Toprak HH, 2017. Spectrometric Determination of Lansoprazole and Domperidone in Tablets by Multivariate Calibration Approach. Journal of Chemical and Pharmaceutical Research 9(3): 103-108.
• Aktaş AH, Ünlü İD, 2016. Application of PCA-ANN Models to Spectrophotometric Data For Quantitative Analysis of A Hydrochlorothiazide and Amiloride Hydrochlorothiazide in Pharmaceutical Formulations. Journal of Chemical and Pharmaceutical Research 8(2): 743-749.
• Aravind D, Kamarapu SK, 2013. 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): 152-161.
• Armbruster DA, Pty T, 2008. Limit of Blank, Limit of Detection and Limit of Quantitation. Clin. Niochem Rev. 29: 49-52.
• Attimarad M, 2011. Simultaneous Determination of Paracetamol and Lornoxicam by RP-HPLC in Bulk and Tablet Formulation. Pharmaceutical Methods 2(1): 61-66.
• Bajpai V, Kumar S, Singh A, Singh J, Negi MPS, Bag SK, Kumar N, Konwar R, Kumar B, 2017. Chemometric Based Identification and Validation of Specific Chemical Markers for Goegraphical, Seasonal and Gender Variations in Tinospora Cordifolia Stem Using HPLC-ESI-QTOF-MS Analysis. Photochemical Analysis 28(4): 277-288.
• Behera S, Ghanty S, Ahmad F, Santra S, Banerjee S, 2012. UV-Visible Spectrophotometric Method Development and Validation of Assay of Paracetamol Tablet Formulation. Journal of Analytical and Bioanalytical Techniques 3-6.
• Bilgili AV, Çullu MA, Aydemir S, 2014. Tuzdan Etkilenmiş Toprakların Yakın Kızılötesi Yansıma Spektroradyometre ve Elektromanyetik Indüksiyon Tekniği Yardımıyla Karakterize Edilebilme Potansiyelinin Araştırılması. Harran Tarım ve Gıda Bilimleri Dergisi 18(1): 32-45.
• Cunha RR, Ribeiro MMAC, Munoz RAA, Richter EM, 2017. Fast Determination of Codeine, Orphenadrine, Promethazine, Scopolamine, Tramadol and Paracetamol in Pharmaceutical Formulations by Capillary Electrophoresis. Journal of Separation Science 40: 1815-1823.
• Deshpande P, Mandawad V, 2018. 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): 5107-5113.
• Dinç E, 2003. Linear Regression Analysis and Its Application to The Multivariate Spectral Calibrations For The Multiresolution of A Ternary Mixture of Caffeine, Paracetamol and Metamizol in Tablets. Journal of Pharmaceutical and Biomedical Analysis 33: 605-615.
• Dinç E, Baleanu D, 2002. Spectrophotometric Quantitative Determination of Cilazapril and Hydrochlorothiazide in Tablets By Chemometric Methods. J. Pharmaceut. Biomed 30: 715-723.
• Ertokuş Pekcan, G, 2018. Determination of Binary Drug Compounds by Spectrophotometric Methods and Determinatıon of The Data Obtained as A Statistical. European Conference on Science, Art & Culture (ECSAC) 43-49.
• Ertokuş GP, Bağrıaçık K, 2017. Simultaneous Determination of Drugs Used For Chronic Active Gastritis Disease by Chemometric Methods. IJLTET 8(4): 173-178.
• Glavanovic S, Glavanovic M, Tomisic V, 2016. Simultaneous Quantitative Determination of Paracetamol and Tramadol in Tablet Formulation Using UV Spectrophotometry and Chemometric Methods. Spectrochimica Acta Part A:Molecular and Biomolecular Spectroscopy 157: 258-264.
• Hajian R, Afshari N, 2012. The Spectrophotometric Multicomponent Analysis of A Ternary Mixture of Ibuprofen, Caffeine and Paracetamol by The Combination of Double Divisor-Ratio Spectra Derivative and H-point Standard Addition Method. E-journal of Chemistry 9(3): 1153-1164.
• Hajian R, Soltaninezhad A, 2013. The Spectrophotometric Multicomponent Analysis of A Ternary Mixture of Paracetamol, Aspirin and Caffeine by The Double Divisor-ratio Spectra Derivative method. Journal of Spectroscopy 1-7.
• Horoz M, Bölükbaş C, Bölükbaş FF, Uzunköy A, Soylu A, 2004. Klaritromisin-Amoksisilin-Lansoprazol Kombinasyonunda Optimal Tedavi Süresi. HrÜ. Tıp Fak. Der. 1: 12-19.
• Kenneth R, 1997. Chemometrics: A practical Guide. John Wiley & Sons. Inc., New York.
• Mansour FR, 2018. A New Innovative Spectrophotometric Method For The Simultaneous Determination of Sofosbuvir and Ledipasvir. Spectrochimica Acta Part A:Molecular and Biomolecular Spectroscopy 18(188): 626-632.
• Miao J, Forget B, Smith K, 2018. Predicting Correlation Coefficients for Monte Carlo Eigenvalue Simulations With Multitype Branching Process Annals of Nuclear Energy 112: 307-321.
• Minitab 18 Statistical Programme. http://www.inovadanismanlik.com.tr/_tu/_urunler/_minitab18/m18.html (13.10.2019)
• Mohamed EH, Lofty HM, Hegazy MA, Mowaka S, 2017. Different Applications of Isosbestic Points, Normalized Spectra and Dual Wavelength as Powerful Tools for Resolution of Multicomponent Mixtures with Severely Overlapping Spectra. Chemistry Central Journal 11(43): 1-15.
• Porfire A, Muntean D, Achim M, Vlase L, Tomuta, I, 2015. Simultaneous Quantification of Simvastatin and Excipients in Liposomes Using Near Infrared Spectroscopy and Chemometry. Journal of Pharmaceutical and Biomedical Analysis 107: 40-49.
• Reiss A, Samide A, Ciobanu G, Dabuleanu I, 2015, Synthesis, Spectral Characterization and Thermal Behaviour of New Metal (II) Complexes with Schiff Base Derived From Amoxicillin. J.Chil. Chem. Soc. 3: 3074-3079.
• Rojanarata T, Opanasopit P, Ngawhirunpat T, Saehuan C, Wiyakrutta S, Meevootisom V, 2010. A Simple, Sensitive and Green Bienzymatic UV-Spectrophotometric Assay of Amoxicillin Formulations. Enzyme and Microbial Technology 46: 292-296.
• Saraan SMD, Sinaga SM, Muchlisyam 2015. Development Method For The Determination of Ternary Mixture of Paracetamol, Ibuprofen and Caffeine in Tablet Dosage Form Using Zero-Crossing Derivative Spectrophotometric. International Journal of Pharmtach Research 7(2): 349-353.
• Shanker K, Kuna SK, Purra S, 2017. Simultaneous Determination of Etodolac and Paracetamol in Bulk Drugs and Pharmaceutical Formulation by HPTLC-Densitometric and UV-derivative Spectrophotometry Methods. IJPSR 8(5): 2056-2063.
• Sharma D, Singh R, Garg R, 2017. Development and Validation of Stability Indicating UV Spectro-photometric Method For The Estimation of Benzydamine Hydrochloride in Bulk and in Pharmaceutical Dosage Form: A Novel Analytical Technique For Conducting In-Vitro Quality Control Tests. International Journal Of Pharmaceutical Sciences And Research 9(2): 678-686.
• Sharma H, Vishakha K, Kumar KV, Bhatta HP, 2016. Validated RP-HPLC Method for Simultaneous Estimation of Paracetamol, Pamabrom and Dicyclomine, Hydrochloride in Bulk and Pharmaceutical Dosage Form. IJPRS 7(1): 316-324.
• Shrivastava A, Gupta VB, 2011. Methods For The Determination of Limit of Detection and Limit of Quantitation of The Analytical Methods. Chronicles of Young Scientist 2(1): 21-25.
• Talluri MVNK, Bairwa MK, Dugga HHT, Srinivas R, 2012. Development and Validation of RP-HPLC and Ultraviolet Spectrophotometric Methods of Analysis for Simultaneous Determination of Paracetamol and Lornoxicam in Pharmaceutical Dosage Forms. Journal of Liquid Chromatography & Related Technologies 35: 129-140.
• Tarhan I, Kara AAIH, 2017. 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 1-8.
• Uyanık A, 2012. Analitik Kimyacılar İçin İstatistik ve Kemometri, Pegem Akademi Yayıncılık 6. Baskı:254-259.
• Wedian F, 2016. Bivariate Analysis For The Determination of Paracetamol and Caffeine in Drug Formulation. Jordan Journal of Chemistry 11(4): 217-225.
• Zahira NK, Prasannakumaran PN, 2015. Analytical Method Development and Validation of Zaltoprofen and Paracetamol in Combined Dosage Form by Ultraviolet Spectrophotometry. IJPSR 6(2): 682-687.