Quality by Design (QbD): A Practical Experimental Design Approach by Blocking and Varying Certain Factors of a Stability-Indicating HPLC Method for Simultaneous Determination of Omeprazole and Ketoprofen

References

• U.S. Department of Health and Human Services Food and Drug Administration. Pharmaceutical Quality for the 21st Century: A Risk-Based Approach. May 2007. http://www.fda.gov/oc/cgmp/report0507.html (accessed).
   Google Scholar
• ICH-Q8 (R2). Pharmaceutical Development, ICH: Geneva, August 2009.
   Google Scholar
• ICH-Q9. Quality Risk Management, ICH: Geneva, November 2005.
   Google Scholar
• ICH-Q10. Pharmaceutical Quality System, ICH: Geneva, June 2008.
   Google Scholar
• Dvŏrák, J.; Hájková, R.; Matysová, L.; Nováková, L.; Koupparis, M. A.; Solich, P. Simultaneous HPLC Determination of Ketoprofen and Its Degradation Products in the Presence of Preservatives in Pharmaceutical. J. Pharm. Biomed. Anal. 2004, 36, 625–629. doi:10.1016/j.jpba.2004.07.018
   PubMed Web of Science ®Google Scholar
• Mohammad, A.; Sharma, S.; Bhawani, S. A. Identification of Ketoprofen in Drug Formulation and Spiked Urine Samples by Micellar Thin Layer Chromatography and its Quantitative Estimation by High Performance Liquid Chromatography. Int. J. Pharm. Tech. Res. 2010, 2 (1), 89–96.
   Google Scholar
• Vittal, G. V.; Deveswaran, R.; Bharath, S.; Basavaraj, B. V.; Madhavan, V. Development of an Analytical Method for Spectrophotometric Estimation of Ketoprofen Using Mixed Cosolvency Approach. Int. J. Pharm. Sci. Res. 2012, 3 (4), 1053–1056.
   Google Scholar
• Pandey, S.; Maheshwari, A Novel Spectroscopic Method for the Estimation of Ketoprofen in Tablet Dosage Form Using Hydrotropic Solubilizitation Phenomenon. R.K. Middle-East J. Sci. Res. 2010, 6 (3), 209–212.
   Google Scholar
• Sheng, J. J.; Kasim, N. A.; Chandrasekharan, R.; Amidon, G. L. Solubilization and Dissolution of Insoluble Weak Acid, Ketoprofen: Effects of pH Combined with Surfactant. Euro. J. Pharm. Sci. 2006, 29, 306–314. doi:10.1016/j.ejps.2006.06.006.
   PubMed Web of Science ®Google Scholar
• Dedania, Z.; Dedania, R.; Karkhanis, V.; Sagar, G V.; Baldania, M.; Sheth, N. R. RP-HPLC Method for Simultaneous Estimation of Omeprazole and Ondansetron in Combined Dosage Forms. Asian J. Res. Chem. 2009, 2 (2), 108–111.
   Google Scholar
• Nataraj, K. S.; Duza, M. B.; Pragallapati, K.; Kumar, D. K. Development and Validation of RP-HPLC Method for the Estimation of Omeprazole in Bulk and Capsule Dosage Forms. Int. Cur. Pharm J. 2012, 1 (11), 366–369. http://www.icpjonline.com/documents/Vol1Issue11/05.pdf (accessed January 2014).
   Google Scholar
• Krishnaiah, V.; Reddy, Y. V. R. Development and Validation of HPLC Method for Simultaneous Determination of Omeprazole and Domperidone. Pharm. Chem. 2012, 4 (1), 455–459. http://derpharmachemica.com/vol4-iss1/DPC-2012-4-1-455-459.pdf (accessed January 2014).
   Google Scholar
• Iuga, C.; Bojiţă, M.; Leucuţa, S. E. Development of a Validated RP-HPLC Method for Separation and Determination of Process-Related Impurities of Omeprazole in Bulk Drugs. FARMACIA 2009, 57 (5), 534–541.
   Web of Science ®Google Scholar
• Ribani, M.; Collins, C. H.; Bottoli, C. B. G. Evaluation of Detection and Quantification Limits in the Determination of Impurities in Orneprazole. J. Chromatogr. A 2007, 1156, 201–205. doi:10.1016/j.chroma.2006.12.080
   PubMed Web of Science ®Google Scholar
• Inglot, T.; Gumieniczek, A.; Mączka, P.; Rutkowska, E. New HPLC Method with Experimental Design and Fluorescence Detection forAnalytical Study of Antihypertensive Mixture, Amlodipine and Valsartan. Am. J. Anal. Chem. 2013, 4, 17–23. doi:10.4236/ajac.20141003
   Google Scholar
• Nistora, I.; Lebrun, P.; Ceccato, A.; Lecomte, F.; Slama, I.; Oprean, R.; Badarau, E.; Dufour, F.; Sourou, K.; Dossou, S.; Fillet, M.; Franc, J.; Liégeoise, O.; Hubert, P.; Rozet, E. Implementation of a Design Space Approach for Enantiomeric Separations in Polar Organic Solvent Chromatography. J. Pharm. Biomed. Anal. 2013, 74, 273–283. http://dx.doi.org/10.1016/j.jpba.2012.10.015 (accessed January 2014).
   PubMed Web of Science ®Google Scholar
• Debrus, B.; Lebrun, P.; Kindenge, J. M.; Lecomte, F.; Ceccato, A.; Caliaro, G.; Mavar, J.; Mbay, T.; Boulanger, B.; Marini, R. D.; Rozet, E.; Hubert, P. H. Innovative High-Performance Liquid Chromatography Method Development for the Screening of 19 Antimalarial Drugs Based on a Generic Approach, Using Design of Experiments, Independent Component Analysis and Design Space. J. Chromatogr. A 2011, 1218, 5205–5215. http://dx.doi.org/10.1016/j.chroma.2011.05.102 (accessed January 2014).
   PubMed Web of Science ®Google Scholar
• Garg, L. K.; Reddy, V. S.; Sait, S. S.; Krishnamurthy, T.; Vali, S. J.; Reddy, A. M. Quality by Design: Design of Experiments Approach Prior to the Validation of a Stability-Indicating HPLC Method for Montelukast. Chromatographia 2013, 76, 1697–1706. doi:10.1007/10337-013-2509-4.
   Web of Science ®Google Scholar
• Debrus, B.; Lebrun, P.; Ceccato, A.; Caliaro, G.; Rozet, E.; Nistor, I.; Oprean, R.; Rupérez, F. J.; Barbas, C.; Boulanger, B.; Hubert, P. Application of New Methodologies Based on Design of Experiments, Independent Component Analysis and Design Space for Robust Optimization in Liquid Chromatography. Anal. Chim. Acta 2011, 691, 33–42. doi:10.1016/j.aca.2011.02.035.
   PubMed Web of Science ®Google Scholar
• Nistor, I.; Cao, M.; Debrus, B.; Lebrun, P.; Lecomte, F.; Rozet, E.; Angenot, L.; Frederich, M.; Oprean, R.; Hubert, P. Application of aNew Optimization Strategy for the Separation of Tertiary Alkaloids Extracted from Strychnos usambarensis Leaves. J. Pharm. Biomed. Anal. 2011, 56, 30–37. http://dx.doi.org/10.1016/ j.jpba.2011.04.02. (accessed January 2014).
   PubMed Web of Science ®Google Scholar
• Monks, K.; Molnár, I.; Rieger, H.-J.; Bogáti, B.; Szabó, E. Aspects of the “Design Space” in High Pressure Liquid Chromatography Method Development. J. Chromatogr. A 2012, 1232, 218–230. doi:10.1016/j.chroma.2010.02.001.
   PubMed Web of Science ®Google Scholar
• Awotwe-Otoo, D.; Agarabi, C.; Faustino, P. J.; Habib, M. J.; Lee, S.; Khan, M. A.; Shah, R. B. Application of Quality by Design Elements for the Development and Optimization of an Analytical Method for Protamine Sulfate. J. Pharm. Biomed. Anal. 2012, 62, 61–67. doi:10.1016/j.jpba.2012.01.002.
   PubMed Web of Science ®Google Scholar
• Musters, J.; Bos, L. V. D.; Kellenbach, E. Applying QbD Principles to Develop a Generic UHPLC Method Which Facilitates Continual Improvement and Innovation Throughout the Product Lifecycle for aCommercial API. Org. Process Res. Dev. 2013, 17, 87–96. dx.doi.org/10.1021/op300292a.
   Web of Science ®Google Scholar
• Molnár, I.; Rieger, H.-J.; Monks, K. E. Aspects of the “Design Space” in High Pressure Liquid Chromatography Method Development. J.Chromatogr. A 2010, 1217, 3193–3200. doi:10.1016/j.chroma.2010.02.001.
   PubMed Web of Science ®Google Scholar
• Karmarkar, S.; Garber, R.; Genchanok, Y.; George, S.; Yang, X.; Hammond, R. Quality by Design (QbD) Based Development of aStability Indicating HPLC Method for Drug and Impurities. J. Chromatogr. Sci. 2011, 49 (6), 439–446.
   PubMed Web of Science ®Google Scholar
• Monks, K. E.; Rieger, H.-J.; Molnár, I. Expanding the Term “Design Space” in High Performance Liquid Chromatography (I). J. Pharm. Biomed. Anal. 2011, 56, 874–879. doi:10.1016/j.jpba.2011.04.015.
   PubMed Web of Science ®Google Scholar
• Zhang, Y. P.; Zhang, Y. J.; Gong, W. J.; Gopalan, A. I.; Lee, K. P. Rapid Separation of Sudan Dyes by Reverse-Phase High Performance Liquid Chromatography Through Statistically Designed Experiments. J. Chromatogr. A 2005, 1098, 183–187. doi:10.1016/j.chroma.2005.10.024.
   PubMed Web of Science ®Google Scholar
• Sivakumar, T.; Manavalan, R.; Muralidharan, C.; Valliappan, K. Multi-Criteria Decision Making Approach and Experimental Design as Chemometric Tools to Optimize HPLC Separation of Domperidone and Pantoprazole. J. Pharm. Biomed. Anal. 2007, 43, 1842–1848. doi:10.1016/j.jpba.2006.12.007.
   PubMed Web of Science ®Google Scholar
• Xavier, C. M.; Basavaiah, K.; Vinay, K. B.; Swamy, N. Quality by Design Approach for the Development and Validation of Glipizide, an Antidiabetic Drug, by RP-UPLC with Application to Formulated Forms and Urine. ISRN Chromatogr. 2013, 738397, 1–10. http://dx.doi.org/10.1155/2013/738397 (accessed December 2013).
   Google Scholar
• Schoenmakers, P.; Abbott, R. W. Optimization of Chromatographic Selectivity-A Guide to Method Development. Anal. Chim. Acta. 1988, 208, 357–358. doi:10.1016/S0003-2670(00)80772-2. ISSN: 0003-2670.
   Google Scholar
• Ihssane, B.; Charrouf, M.; Abourriche, A.; Abboud, Y.; Bouabidi, A.; Bennamara, A.; Saffaj, T. Optimization and Validation of a New High-Performance Liquid Chromatographic Method for Analysis of Acetazolamide in Tablets Using Box-Behnken Statistical Experiment Design. Acta Chromatogr. 2011, 23 (1), 41–57. doi:10.1556/AChrom.23.2011.1.2.
   Web of Science ®Google Scholar
• Gavin, P. F.; Olsen, B. A. A Quality by Design Approach to Impurity Method Development for Atomoxetine Hydrochloride (LY139603). J. Pharm. Biomed. Anal. 2008, 46, 431–441. doi:10.1016/j.jpba.2007.10.037.
   PubMed Web of Science ®Google Scholar
• Hibbert, D. B. Experimental Design in Chromatography: A Tutorial Review. J. Chromatogr. B 2012, 910, 2–13. doi:10.1016/j.jchromb.2012.01.020.
   PubMed Web of Science ®Google Scholar
• Rozet, E.; Lebrun, P.; Debrus, B.; Boulanger, B.; Hubert, P. Design Spaces for Analytical Methods. Trends Anal. Chem. 2013, 42, 157–167. doi:http://dx.doi.org/10.1016/j.trac.2012.09.007.
   Web of Science ®Google Scholar
• Molnar, I. Computerized Design of Separation Strategies by Reversed-Phase Liquid Chromatography: Development of DryLab Software. J.Chromatogr. A 2002, 965, 175–194. PII: S0021–9673(02) 00731–8.
   PubMed Web of Science ®Google Scholar
• Trivedi, B. Quality by Design (QbD) in Pharmaceuticals. Int. J.Pharm. Pharm. Sci. 2012, 4 (1), 17–29.
   Google Scholar
• Vogt, F. G.; Kord, A. S. Development of Quality-by-Design Analytical Methods. J. Pharm. Sci. 2011, 100 (3), 797–812. doi:10.1002/jps.22325.
   PubMed Web of Science ®Google Scholar
• ICH-Q2 (R1). Validation of Analytical Procedures: Text and Methodology, ICH: Geneva, November 2005.
   Google Scholar