DEVELOPMENT AND VALIDATION OF CHEMOMETRIC ASSISTED SPECTROPHOTOMETRIC TECHNIQUE FOR SIMULTANEOUS ESTIMATION OF CINITAPRIDE AND PANTOPRAZOLE FROM BULK AND COMBINED DOSAGE FORM
Abstract
This paper describes two sensitive, accurate and precise chemometric spectrophotometric methods for the simultaneous determination of Cinitapride hydrogen tartarate (CNT) and Pantoprazole sodium (PANTO) in bulk powder and capsules without prior separation. Multivariate calibration chemometric methods are proposed for simultaneous determination of CNT and PANTO. The chemometric methods applied are Principal Component Regression (PCR) and Partial Least Squares (PLS). These approaches are successfully applied to quantify both drugs using the information included in the absorption spectra of appropriate solutions. In these multivariate methods, calibration sets of standard samples composed of different mixtures of CNT and PANTO have been designed. The methods were validated according to The International Conference on Harmonization (ICH) guidelines. The specificity of the proposed methods was tested using laboratory-prepared mixtures. The developed methods were successfully applied for the determination of CNT and PANTO in bulk powder and dosage form combination.
Keywords:
Chemometric, Cinitapride hydrogen tartarate, Pantoprazole sodium, Principal Component Regression (PCR), Partial Least Square (PLS)DOI
https://doi.org/10.25004/IJPSDR.2015.070213References
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11. Pandya J, Solanki S, Patel M. Development and Validation of Differential Spectrophotometric Method for Determination of Pantoprazole in Tablet Dosage Form. J of Pharm Science and Bio-Scientific Res. 2012; 2(1): 2-4.
12. Okram Z, Basavaiah K. Validated Spectrophotometric Determination of Pantoprazole Sodium in Pharmaceuticals Using Ferric Chloride and Two Chelating Agents. Int J of Chem Res. 2010; 2(1): 624-632.
13. Rao K, Keshar N, Choudhary P, Pattnaik A. RP-HPLC Method for Estimation of Pantoprazole Sodium. Int Med and Bio Science. 2012; 1(1): 1-5.
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16. Patel S. High Performance Thin Layer Liquid Chromatography Estimation for Pantoprazole in Injection. Int Res J of Pharm. 2011; 2(3): 132-133.
17. Kalaichelvi R, Fatima Rose M, Vadivel K, Jayachandran E. Simple Extractive Colorimetric Determination of Pantoprazole Sodium by Acid Dye Complexation Method in Solid Dosage Form. Int J of Chem Res. 2010; 1(1): 6-8.
18. Basavaiah K, Tharpa K, Rajendraprasad N. Titrimetric and Spectrophotometric Assay of Pantoprazole in Pharmaceuticals Using Permanganate. J of the Mexican Society. 2009; 53(1): 34-40.
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22. Geladi P, Kowalski BR. Partial Least Squares Regression: A Tutorial. Anal Chim Acta. 1986; 185: 1-17.
23. Haaland DM, Thomas EV. Partial Least Squares Methods for Spectral Analysis: Relation to Other Quantitative Calibration Methods and the Extraction of Qualitative Information. Anal Chem. 1988; 60: 1193-202.
24. Haaland DM, Thomas EV. Comparison of Multivariate Calibration Methods for Quantitative Spectral Analysis. Anal Chem. 1990; 62: 1091-1099.
25. Ibrahim N, Rizk M, Ibrahim A, Tawakkol S, Ali S. Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium by Using Chemometric Method with Multivariate Calibration and HPLC Method With Design of Experiment. Int J of Pharm and Pharm Sci. 2014; 6(1): 419-425.
26. Meras ID, Pena AMdl, Mansilla AE, Salinas F. Multicomponent Determination of Flavour Enhancers in Food Preparations By Partial Least Squares and Principal Component Regression Modelling of Spectrophotometric Data. The Analyst. 1993; 118(7): 807-813.
27. Brereton RG, Multilevel Multifactor Designs for Multivariate Calibration. The Analyst. 1997; 122: 1521-1529.
28. Ni YG, G X. Simultaneous Spectrophotometric Determination of Mixtures of Food Colorants. Anal Chim Acta. 1997; 354: 163-171.
29. O'Haver TC, Green GL. Numerical Error Analysis of Derivative Spectrometry for the Quantitative Analysis of Mixtures. Anal Chem. 1976; 48: 312-318.
30. O'Haver TC, Green GL. Derivative and Wavelength Modulation Spectrometry. Anal Chem.1979; 51: 91 A-100 A.
31. Kramer R, Chemometric Techniques for Quantitative Analysis. New York, Marcel Dekker Inc. 1998.
32. ICH, Q2 (R1), In proceedings of the International Conference on Harmonisation, Validation of Analytical Procedure: Text and Methodology. Geneva.2005.
33. Danzer K, Otto M, Currie LA. Guidelines for Calibration in Analytical Chemistry Part 2: Multicomponent Calibration (IUPAC Technical Report). 2004; 76(6): 1215-1225.
2. Thangabalan B, Prabhakar AE, Kalaichelvi R, Vijayraj P, Reddy KC. UV Spectrophotometric Method for Determination of Cinitapride in Pure and its Solid Dosage Form. E- J of Chem. 2009; 6: 21-24.
3. Thangabalan B, Prabhakar AE, Vijayraj P. Validated Extractive Spectrophotometric Estimation of Cinitapride in Pure and Solid Dosage Form. Int J of Pharm and Pharm Science. 2010; 2: 153-155.
4. Homaira S, Dey A, Raju A, Sanaullah S. Applications of Colorimetric Methods for the Determination of Cinitapride Hydrogen Tartarate in Drug Formulations. Int J of Pharm and Pharm Science. 2010; 2: 134-136.
5. Roy SMN, Mangaonkar KV, Desai AY, Yetal SM. RP-HPLC Method for the Determination of Cinitapride in The Presence of its Degradation Products in Bulk Drugs. E- J of Chem. 2010; 7: 311-319.
6. Kumarand M, Shrinivasan BP. Stability Indicating HPTLC Method for Determination of Cinitapride Hydrogen Tartarate in Bulk and Pharmaceutical Formulation. IPC Abstract. 2009; 530 section 41.
7. Roy SMN, Yetal SHM, Chavan SV, Pradhan VR, Joshi SS. Determination of Free Levels of Cinitapride in Human Plasma by Liquid Chromatography Tandem-Mass Spectrometry. E- J of Chem. 2008; 5: 3453-3460.
8. Commission, Indian Pharmacopoeia, Ministry of Health and Family Welfare. Ghaziabad. 2010; 3:1856-1857.
9. European Directorate for the Quality of Medicines and Healthcare, European Pharmacopoeia. 2: 2664-2665.
10. Kumar R, Singh H, Singh P. Development of UV Spectrophotometric Method for Estimation of Pantoprazole in Pharmaceutical Dosage Form. J of Chem and Pharm Res. 2011; 3(2): 113-117.
11. Pandya J, Solanki S, Patel M. Development and Validation of Differential Spectrophotometric Method for Determination of Pantoprazole in Tablet Dosage Form. J of Pharm Science and Bio-Scientific Res. 2012; 2(1): 2-4.
12. Okram Z, Basavaiah K. Validated Spectrophotometric Determination of Pantoprazole Sodium in Pharmaceuticals Using Ferric Chloride and Two Chelating Agents. Int J of Chem Res. 2010; 2(1): 624-632.
13. Rao K, Keshar N, Choudhary P, Pattnaik A. RP-HPLC Method for Estimation of Pantoprazole Sodium. Int Med and Bio Science. 2012; 1(1): 1-5.
14. Mohankandhasamy R, Dharuman J, Thiagarajan M. High Performance Liquid Chromatography Method for Quantification of Pantoprazole in Rat Plasma. Int J of Chemtech Res. 2010; 2(2): 585-594.
15. Birajdarl A, Meyenathan S, Suresh B. Determination of Mosapride and Pantoprazole in Fixed Dose Combination by UV Spectrophotometric Method and RP-HPLC. Int J of Pharm Stud and Res. 2011; 2(2): 29-36.
16. Patel S. High Performance Thin Layer Liquid Chromatography Estimation for Pantoprazole in Injection. Int Res J of Pharm. 2011; 2(3): 132-133.
17. Kalaichelvi R, Fatima Rose M, Vadivel K, Jayachandran E. Simple Extractive Colorimetric Determination of Pantoprazole Sodium by Acid Dye Complexation Method in Solid Dosage Form. Int J of Chem Res. 2010; 1(1): 6-8.
18. Basavaiah K, Tharpa K, Rajendraprasad N. Titrimetric and Spectrophotometric Assay of Pantoprazole in Pharmaceuticals Using Permanganate. J of the Mexican Society. 2009; 53(1): 34-40.
19. Vaithiyanathan S, Rajappan M, Valliappan K. Stability Indicating RP-HPLC Method for the Simultaneous Determination of Pantoprazole, Rabeprazole, Lansoprazole and Domeperidone from Their Combined Dosage Forms. Int J of Drug Develop and Res. 2011; 3(4): 323-335.
20. Badawy AM, Mostafa NM, Abd elaleem AB, Lamie NT. Stability Indicating PLS and PCR Chemometric Methods for the Determination of Rosuastatin in Presence of its Two Degradation Products. Int J of Pharm and Pharm Sci.2011; 3(3): 232-237.
21. Espinosa MA, Munoz de la Pena A, Salinas F, Martinez Galera M. Simultaneous Determination of 2-Furfuraldehyde and 5-Hydroxymethylfurfuraldehyde and Malonaldehyde in Mixtures by Derivative Spectrophotometry and Partial Least Squares Analysis. Anal Chim Acta. 1993; 276(1): 141-149.
22. Geladi P, Kowalski BR. Partial Least Squares Regression: A Tutorial. Anal Chim Acta. 1986; 185: 1-17.
23. Haaland DM, Thomas EV. Partial Least Squares Methods for Spectral Analysis: Relation to Other Quantitative Calibration Methods and the Extraction of Qualitative Information. Anal Chem. 1988; 60: 1193-202.
24. Haaland DM, Thomas EV. Comparison of Multivariate Calibration Methods for Quantitative Spectral Analysis. Anal Chem. 1990; 62: 1091-1099.
25. Ibrahim N, Rizk M, Ibrahim A, Tawakkol S, Ali S. Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium by Using Chemometric Method with Multivariate Calibration and HPLC Method With Design of Experiment. Int J of Pharm and Pharm Sci. 2014; 6(1): 419-425.
26. Meras ID, Pena AMdl, Mansilla AE, Salinas F. Multicomponent Determination of Flavour Enhancers in Food Preparations By Partial Least Squares and Principal Component Regression Modelling of Spectrophotometric Data. The Analyst. 1993; 118(7): 807-813.
27. Brereton RG, Multilevel Multifactor Designs for Multivariate Calibration. The Analyst. 1997; 122: 1521-1529.
28. Ni YG, G X. Simultaneous Spectrophotometric Determination of Mixtures of Food Colorants. Anal Chim Acta. 1997; 354: 163-171.
29. O'Haver TC, Green GL. Numerical Error Analysis of Derivative Spectrometry for the Quantitative Analysis of Mixtures. Anal Chem. 1976; 48: 312-318.
30. O'Haver TC, Green GL. Derivative and Wavelength Modulation Spectrometry. Anal Chem.1979; 51: 91 A-100 A.
31. Kramer R, Chemometric Techniques for Quantitative Analysis. New York, Marcel Dekker Inc. 1998.
32. ICH, Q2 (R1), In proceedings of the International Conference on Harmonisation, Validation of Analytical Procedure: Text and Methodology. Geneva.2005.
33. Danzer K, Otto M, Currie LA. Guidelines for Calibration in Analytical Chemistry Part 2: Multicomponent Calibration (IUPAC Technical Report). 2004; 76(6): 1215-1225.
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01-03-2015
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“DEVELOPMENT AND VALIDATION OF CHEMOMETRIC ASSISTED SPECTROPHOTOMETRIC TECHNIQUE FOR SIMULTANEOUS ESTIMATION OF CINITAPRIDE AND PANTOPRAZOLE FROM BULK AND COMBINED DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 2, Mar. 2015, pp. 198-04, https://doi.org/10.25004/IJPSDR.2015.070213.
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How to Cite
“DEVELOPMENT AND VALIDATION OF CHEMOMETRIC ASSISTED SPECTROPHOTOMETRIC TECHNIQUE FOR SIMULTANEOUS ESTIMATION OF CINITAPRIDE AND PANTOPRAZOLE FROM BULK AND COMBINED DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 2, Mar. 2015, pp. 198-04, https://doi.org/10.25004/IJPSDR.2015.070213.
