Analytical QbD-based systematic bioanalytical HPLC method development for estimation of quercetin dihydrate

References

• D’Andrea, G. Quercetin: A Flavonol with Multifaceted Therapeutic Applications? Fitoterapia 2015, 106, 256–271.
   PubMed Web of Science ®Google Scholar
• Zhang, M.; Swarts, S. G.; Yin, L.; Liu, C.; Tian, Y.; Cao, Y.; Swarts, M.; Yang, S.; Zhang, S. B.; Zhang, K.; Ju, S.; Olek, Jr., D. J.; Schwartz, L.; Keng, P. C.; Howell, R.; Zhang, L.; Okunieff, P. Antioxidant Properties of Quercetin. Adv. Exp. Med. Biol. 2011, 701, 283–289.
   PubMed Web of Science ®Google Scholar
• Rice-Evans, C. A.; Miller, N. J.; Bolwell, P. G.; Bramley, P. M.; Pridham, J. B. The Relative Antioxidant Activities of Plant-derived Polyphenolic Flavonoids. Free Rad. Res. 1995, 22, 375–383.
   PubMed Web of Science ®Google Scholar
• Ternaux, J. P.; Portalier, P. Effect of Quercetine on Survival and Morphological Properties of Cultured Embryonic Rat Spinal Motoneurones. Neurosci. Lett. 2002, 332, 33–36.
   PubMed Web of Science ®Google Scholar
• Middleton, E.; Kandaswami, C.; Theoharides, T. C. The Effects of Plant Flavonoids on Mammalian Cells: Implications for Inflammation, Heart Disease, and Cancer. Pharmacol. Rev. 2000, 52, 673–751.
   PubMed Web of Science ®Google Scholar
• Dok-Go, H.; Lee, K. H.; Kim, H. J.; Lee, E. H.; Lee, J.; Song, Y. S.; Lee, Y. H.; Jin, C.; Lee, Y. S.; Cho, J. Neuroprotective Effects of Antioxidative Flavonoids, Quercetin, (+)-Dihydroquercetin and Quercetin 3-Methyl ether, Isolated from Opuntia ficus-indica var. saboten. Brain Res. 2003, 965, 130–136.
   PubMed Web of Science ®Google Scholar
• Geleijnse, J. M.; Launer, L. J.; Van der Kuip, D. A.; Hofman, A.; Witteman, J. C. Inverse Association of Tea and Flavonoid Intakes with Incident Myocardial Infarction: The Rotterdam Study. Am. J. Clin. Nutr. 2002, 75, 880–886.
   PubMed Web of Science ®Google Scholar
• Ang, L. F.; Yam, M. F.; Fung, Y. T.; Kiang, P. K.; Darwin, Y. HPLC Method for Simultaneous Quantitative Detection of Quercetin and Curcuminoids in Traditional Chinese Medicines. J. Pharmacopunct. 2014, 17, 36–49.
   PubMedGoogle Scholar
• Burak, C.; Brull, V.; Langguth, P.; Zimmermann, B. F.; Stoffel, W. B.; Sausen, U.; Stehle, P.; Wolffram, S.; Egert, S. Higher Plasma Quercetin Levels Following Oral Administration of an Onion Skin Extract Compared with Pure Quercetin Dihydrate in Humans. Eur. J. Nutr. 2015, 56, 343–353.
   PubMed Web of Science ®Google Scholar
• Shi, Y.; Williamson, G. Comparison of the Urinary Excretion of Quercetin Glycosides from Red Onion and Aglycone from Dietary Supplements in Healthy subjects: A Randomized, Single-blinded, Cross-over Study. Food Funct. 2015, 6, 1443–1448.
   PubMed Web of Science ®Google Scholar
• ICH Guideline. Validation of Analytical Procedures: Text and Methodology, 2005, http://www.ich.org.
   Google Scholar
• Monks, K.; Molnar, I.; Rieger, H. J.; Bogati, B.; Szabo, E. Quality by Design: Multidimensional Exploration of the Design Space in High Performance Liquid Chromatography Method Development for Better Robustness Before Validation. J. Chromatogr. A 2011, 1232, 218–230.
   PubMed Web of Science ®Google Scholar
• Lionberger, R. A.; Lee, S. L.; Lee, L.; Raw, A.; Yu, L. X. Quality by Design: Concepts for ANDAs. AAPS J. 2008, 10, 268–276.
   PubMed Web of Science ®Google Scholar
• Singh, B.; Beg, S. Quality by Design in Product Development Life Cycle. Chronicle Pharmabiz 2013, 27, 72–79.
   Google Scholar
• Bhutani, H.; Kurmi, M.; Singh, S.; Beg, S.; Singh, B. Quality by Design (QbD) in Analytical Sciences: An Overview. Pharma Times 2014, 46, 71–75.
   Google Scholar
• Singh, B. Quality by Design (QbD) for Holistic Pharma Excellence and Regulatory Compliance. Pharma Times 2014, 46, 26–33.
   Google Scholar
• Beg, S.; Kohli, K.; Swain, S.; Hasnain, M. S. Development and Validation of RP-HPLC Method for Quantitation of Amoxicillin Trihydrate in Bulk and Pharmaceutical Formulations Using Box–Behnken Experimental Design. J. Liq. Chromatogr. Relat. Technol. 2011, 35, 393–406.
   Web of Science ®Google Scholar
• Krishna, M. V.; Dash, R. N.; Reddy, B. J.; Venugopal, P.; Sandeep, P.; Madhavi, G. Quality by Design (QbD) Approach to Develop HPLC Method for Eberconazole Nitrate: Application Oxidative and Photolytic Degradation Kinetics. J. Saudi Chem. Soc. 2012, 20, S313–S322.
   Web of Science ®Google Scholar
• Murthy, M. V.; Krishnaiah, C.; Srinivas, K.; Rao, K. S.; Kumar, N. R.; Mukkanti, K. Development and Validation of RP-UPLC Method for the Determination of Darifenacin Hydrobromide, Its Related Compounds and Its Degradation Products Using Design of Experiments. J. Pharmaceut. Biomed. Anal. 2013, 72, 40–50.
   PubMed Web of Science ®Google Scholar
• Rozet, E.; Ziemons, E.; Marini, R. D.; Boulanger, B.; Hubert, P. Quality by Design Compliant Analytical Method Validation. Anal. Chem. 2012, 84, 106–112.
   PubMed Web of Science ®Google Scholar
• Skrdla, P. J.; Wang, T.; Antonucci, V.; Dowling, T.; Ge, Z.; Ellison, D.; Curran, J.; Mohan, G.; Wyvratt, J. Use of a Quality-by-design Approach to Justify Removal of the HPLC Weight % Assay from Routine API Stability Testing Protocols. J. Pharmaceut. Biomed. Anal. 2009, 50, 794–796.
   PubMed Web of Science ®Google Scholar
• Beg, S.; Sharma, G.; Katare, O. P.; Lohan, S.; Singh, B. Development and Validation of a Stability-indicating Liquid Chromatographic Method for Estimating Olmesartan Medoxomil Using Quality by Design. J. Chromatogr. Sci. 2015, 53, 1048–1059.
   PubMed Web of Science ®Google Scholar
• Beg, S.; Chaudhary, V.; Sharma, G.; Garg, B.; Panda, S. S.; Singh, B. QbD-oriented Development and Validation of a Bioanalytical Method for Nevirapine with Enhanced Liquid–Liquid Extraction and Chromatographic Separation. Biomed. Chromatogr. 2016, 30, 818–828.
   PubMed Web of Science ®Google Scholar
• Khurana, R. K.; Beg, S.; Lal, D.; Katare, O. P.; Singh, B. Analytical Quality by Design Approach for Development of a Validated Bioanalytical UPLC Method of Docetaxel Trihydrate. Curr. Pharmaceut. Anal. 2015, 11, 180–192.
   Web of Science ®Google Scholar
• Sandhu, P. S.; Beg, S.; Katare, O. P.; Singh, B. QbD-driven Development and Validation of a HPLC Method for Estimation of Tamoxifen Citrate with Improved Performance. J. Chromatogr. Sci. 2016, 54, 1373–1384.
   PubMed Web of Science ®Google Scholar
• Hasnain, M. S.; Siddiqui, S.; Rao, S.; Mohanty, P.; Ara, T. J.; Beg, S. QbD-driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Fluoxetine in Human Plasma. J. Chromatogr. Sci. 2016, 54, 736–743.
   PubMed Web of Science ®Google Scholar
• Singh, B.; Kapil, R.; Nandi, M.; Ahuja, N. Developing Oral Drug Delivery Systems Using Formulation by Design: Vital Precepts, Retrospect and Prospects. Exp. Opin. Drug Deliv. 2011, 8, 1341–1360.
   PubMed Web of Science ®Google Scholar
• Singh, B.; Raza, K.; Beg, S. Developing “Optimized” Drug Products Employing “Designed” Experiments. Chem. Ind. Digest 2013, 6, 70–76.
   Google Scholar
• Fahmy, R.; Kona, R.; Dandu, R.; Xie, W.; Claycamp, G.; Hoag, S. W. Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-compacted Ciprofloxacin Hydrochloride Immediate-release Tablets. AAPS PharmSciTech 2012, 13, 1243–1254.
   PubMed Web of Science ®Google Scholar
• Vora, C.; Patadia, R.; Mittal, K.; Mashru, R. Risk Based Approach for Design and Optimization of Stomach Specific Delivery of Rifampicin. Int. J. Pharmaceut. 2013, 455, 169–181.
   PubMed Web of Science ®Google Scholar
• Singh, B.; Kumar, R.; Ahuja, N. Optimizing Drug Delivery Systems Using Systematic “Design of Experiments.” Part I: Fundamental Aspects. Crit. Rev. Ther. Drug Carrier Syst. 2005, 22, 27–105.
   PubMed Web of Science ®Google Scholar
• Kumar, V.; Bhutani, H.; Singh, S. ICH Guidance in Practice: Validated Stability-indicating HPLC Method for Simultaneous Determination of Ampicillin and Cloxacillin in Combination Drug Products. J. Pharmaceut. Biomed. Anal. 2007, 43, 769–773.
   PubMed Web of Science ®Google Scholar
• Kapil, R.; Dhawan, S.; Singh, B. Development and Validation of a Spectroflourimetric Method for the Estimation of Rivastigmine in Formulations. Indian J. Pharmaceut. Sci. 2009, 71, 585–589.
   PubMed Web of Science ®Google Scholar