Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Review Article

Pitfalls and Opportunities in the Execution of Quality by Design in Analytical Sciences

Author(s): Prashant K. Chaturvedi, Kalyani H. Joshi, Shruti Chopra*, Savita J. Tauro and Pintu B. Prajapati

Volume 19, Issue 5, 2023

Published on: 07 June, 2023

Page: [399 - 412] Pages: 14

DOI: 10.2174/1573412919666230517141015

Price: $65

conference banner
Abstract

Quality by Design (QbD) is a systematic approach integrated with quality risk management. It uses different design approaches followed by statistical analysis to yield a quality product. Now, the pharmaceutical industries are intrested in the application of QbD principles to analytical methods and term it as Analytical QbD (AQbD), which does not essentially mean less analytical testing; to a particular extent, it means the right analysis at the right time, supported by science and risk evaluation which ensures that the analytical method can be improved throughout its life cycle. However, for that, the analyst must have sound knowledge of Analytical Target Profile (ATP), method performance characteristics, risk assessment, choice of Design of Experiment (DoE), optimization of Method Operable Design Region (MODR). Some papers have cited the importance, regulatory flexibility, theoretical aspects, and statistical analysis of AQbD, but only a few discuss the core issue of gradual implementation of QbD in analytical sciences. For seamless transition, researchers need clarification on AQbD terminologies, acceptable methods, criteria to embrace critical quality attributes (CQAs), and standards to judge the adequacy of controls. This paper summarizes the challenges and solutions for the implementation of AQbD.

« Previous Next »
Graphical Abstract

[1]
Panda, S.S.; Beg, S.; Bera, R.; Rath, J. Implementation of quality by design approach for developing chromatographic methods with enhanced performance: A mini review. J. Anal. Pharm. Res., 2016, 2, 00039.
[2]
Tei, A.; Deidda, R.; Avohou, H.T.; Jambo, H.; Dispas, A.; Orlandini, S.; Hubert, P.; Ziemons, E.; Hubert, C. Analytical quality by design, life cycle management, and method control. AAPS J., 2019, 24, 34.
[http://dx.doi.org/10.1208/s12248-022-00685-2]
[3]
Deidda, R.; Avohou, H.T.; Jambo, H.; Dispas, A.; Orlandini, S.; Hubert, P.; Ziemons, E.; Hubert, C. Principles of Analytical Quality by Design for the development of quality control methods in a pharmaceutical context., 2019. Available from: https://orbi.uliege.be/bitstream/2268/235005/1/Abstract_BSPS_DEIDDA.pdf
[4]
Tuesuwan, B.; Vongsutilers, V. Nitrosamine contamination in pharmaceuticals: Threat, impact, and control. J. Pharm. Sci., 2021, 110(9), 3118-3128.
[http://dx.doi.org/10.1016/j.xphs.2021.04.021] [PMID: 33989680]
[5]
Alhakeem, M.A.; Ghica, M.V.; Pîrvu, C.D.; Anuța, V.; Popa, L. Analytical quality by design with the lifecycle approach: A modern epitome for analytical method development. Acta Med. Marisiensis, 2019, 65(2), 37-44.
[http://dx.doi.org/10.2478/amma-2019-0010]
[6]
Deidda, R.; Orlandini, S.; Hubert, P.; Hubert, C. Risk-based approach for method development in pharmaceutical quality control context: A critical review. J. Pharm. Biomed. Anal., 2018, 161, 110-121.
[http://dx.doi.org/10.1016/j.jpba.2018.07.050] [PMID: 30145448]
[7]
ICH Q14:. Analytical Procedure Development and Revision of Q2(R1); Analytical Validation: Geneva, Switzerland, 2018, p. 3.
[8]
Sharma, S.; Phale, M. Stress degradation studies of furosemide and development and validation of SIAM RP-HPLC method for its quantification. World J. Pharm. Res., 2017, 6(5), 906-920.
[9]
Kurmi, M.; Kumar, S.; Singh, B.; Singh, S. Implementation of design of experiments for optimization of forced degradation conditions and development of a stability-indicating method for furosemide. J. Pharm. Biomed. Anal., 2014, 96, 135-143.
[http://dx.doi.org/10.1016/j.jpba.2014.03.035] [PMID: 24742772]
[10]
Attia, K.A.M.; El-Abasawi, N.M.; El-Olemy, A.; Serag, A. Stability-indicating HPLC-DAD method for the determination of simeprevir. Anal. Chem. Lett., 2017, 7(1), 43-51.
[http://dx.doi.org/10.1080/22297928.2017.1287004]
[11]
Vanitha, C.; Sv, S.; Bhaskar, R.K.; Vanitha, C.; Satyanarayana, SV; Bhaskar, R.K. Quality by design approach to stability-indicating reverse-phase high-performance liquid chromatography method development, optimization, and validation for the estimation of simeprevir in bulk drug. Asian J. Pharm. Clin. Res., 2019, 12(15), 93-100.
[http://dx.doi.org/10.22159/ajpcr.2019.v12i5.32027]
[12]
Peraman, R.; Nayakanti, D.; Dugga, H.H.; Kodikonda, S. Development and validation of a stability-indicating assay of etofenamate by RP-HPLC and characterization of degradation products. Sci. Pharm., 2013, 81(4), 1017-1028.
[http://dx.doi.org/10.3797/scipharm.1305-19] [PMID: 24482770]
[13]
Peraman, R.; Bhadraya, K.; reddy, Y.P.; reddy, C.S.; Lokesh, T. Analytical quality by design approach in RP-HPLC method development for the assay of etofenamate in dosage forms. Indian J. Pharm. Sci., 2015, 77(6), 751-757.
[http://dx.doi.org/10.4103/0250-474X.174971] [PMID: 26997704]
[14]
Bhavar, G.B.; Pekamwar, S.S.; Aher, K.B.; Chaudhari, S.R. Development and validation of RP-HPLC method for the determination of valacyclovir hydrochloride and its related substances in tablet formulation. Int. J. Pharm. Sci. Rev. Res., 2014, 25(1), 53-58.
[15]
Katakam, P.; Dey, B.; Hwisa, N.T.; Assaleh, F.H.; Chandu, B.R.; Singla, R.K.; Mitra, A. An experimental design approach for impurity profiling of valacyclovir-related products by RP-HPLC. Sci. Pharm., 2014, 82(3), 617-630.
[http://dx.doi.org/10.3797/scipharm.1403-20] [PMID: 25853072]
[16]
Ghanem, M.M.; Abu-Lafi, S.A. Development and validation of a stability-indicating HPLC method for the simultaneous determination of sulfadiazine sodium and trimethoprim in injectable solution formulation. Sci. Pharm., 2013, 81(1), 167-182.
[http://dx.doi.org/10.3797/scipharm.1210-12] [PMID: 23641336]
[17]
Thakur, K.; Sharma, G.; Singh, B.; Chhibber, S.; Katare, O.P. Analytical QbD-integrated method development and validation of silver sulphadiazine in pure drug and topical nanocarrier (s). Anal. Chem. Lett., 2018, 8(6), 727-746.
[http://dx.doi.org/10.1080/22297928.2018.1552537]
[18]
Hvass, A.; Skelbaek-Pedersen, B. Determination of protamine peptides in insulin drug products using reversed phase high performance liquid chromatography. J. Pharm. Biomed. Anal., 2005, 37(3), 551-557.
[http://dx.doi.org/10.1016/j.jpba.2004.11.028] [PMID: 15740916]
[19]
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.
[http://dx.doi.org/10.1016/j.jpba.2012.01.002] [PMID: 22316620]
[20]
Damle, M.C.; Mehendre, R.; Khetre, A.B.; Sinha, P.K. Development and validation of stability indicating RP-HPLC method for voriconazole. Indian J. Pharm. Sci., 2009, 71(5), 509-514.
[http://dx.doi.org/10.4103/0250-474X.58178] [PMID: 20502568]
[21]
Srinubabu, G.; Raju, C.A.I.; Sarath, N.; Kumar, P.K.; Rao, J.V.L.N.S. Development and validation of a HPLC method for the determination of voriconazole in pharmaceutical formulation using an experimental design. Talanta, 2007, 71(3), 1424-1429.
[http://dx.doi.org/10.1016/j.talanta.2006.04.042] [PMID: 19071468]
[22]
Sharma, R.; Pancholi, S. RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions. Acta Pharm., 2010, 60(1), 13-24.
[http://dx.doi.org/10.2478/v10007-010-0010-2] [PMID: 20228038]
[23]
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(7), 1048-1059.
[http://dx.doi.org/10.1093/chromsci/bmu165] [PMID: 25583970]
[24]
Garg, N.K.; Sharma, G.; Singh, B.; Nirbhavane, P.; Katare, O.P. Quality by design (QbD)-based development and optimization of a simple, robust RP-HPLC method for the estimation of methotrexate. J. Liq. Chromatogr. Relat. Technol., 2015, 38(17), 1629-1637.
[http://dx.doi.org/10.1080/10826076.2015.1087409]
[25]
Krishna, M.V.; Dash, R.N.; Jalachandra Reddy, B.; 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., 2016, 20, S313-S322.
[http://dx.doi.org/10.1016/j.jscs.2012.12.001]
[26]
Bhutani, H.; Kurmi, M.; Singh, S.; Beg, S.; Singh, B. Quality by design (QbD) in analytical sciences: An overview. Qual. Assur., 2004, 3, 39.
[27]
Dispas, A.; Avohou, H.T.; Lebrun, P.; Hubert, P.; Hubert, C. ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances. Trends Analyt. Chem., 2018, 101, 24-33.
[http://dx.doi.org/10.1016/j.trac.2017.10.028]
[28]
Terzić, J.; Popović, I.; Stajić, A.; Tumpa, A.; Jančić-Stojanović, B. Application of analytical quality by design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. J. Pharm. Biomed. Anal., 2016, 125, 385-393.
[http://dx.doi.org/10.1016/j.jpba.2016.04.022] [PMID: 27131148]
[29]
Shao, J.; Cao, W.; Qu, H.; Pan, J.; Gong, X. A novel quality by design approach for developing an HPLC method to analyze herbal extracts: A case study of sugar content analysis. PLoS One, 2018, 13(6), e0198515.
[http://dx.doi.org/10.1371/journal.pone.0198515] [PMID: 29883452]
[30]
Fukuda, I.M.; Pinto, C.F.F.; Moreira, C.S.; Saviano, A.M.; Lourenço, F.R. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Braz. J. Pharm. Sci., 2018, 54(spe), 54.
[http://dx.doi.org/10.1590/s2175-97902018000001006]
[31]
Breeze, J.S.P. QBD in Analytical Development A Glance in Sun Pharma; Indian Pharmaceutical Alliance, 2019.
[32]
Pharmaceutical development Q8(R2). International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2009, 4.
[33]
Guideline on process validation for finished products- information and data to be provided in regulatory submissions; European Medicines Agency, 2016.
[34]
European Medicines Agency; European Medicines Agency, 2012.
[35]
Pharmaceutical Quality for the 21st Century A Risk- Based Approach Progress Report; U.S. Food and Drug Administration, 2007.
[36]
Validation of analytical procedures Q2(R2). In: International Council for Harmonisation; ICH, 2022; pp. 1-34.
[37]
Tol, T.; Tawde, H.; Gorad, S.; Jagdale, A.; Kulkarni, A.; Kasbale, A.; Desai, A.; Samanta, G. Optimization of a liquid chromatography method for the analysis of related substances in daclatasvir tablets using design of experiments integrated with the steepest ascent method and Monte Carlo simulation. J. Pharm. Biomed. Anal., 2020, 178, 112943.
[http://dx.doi.org/10.1016/j.jpba.2019.112943] [PMID: 31677954]
[38]
Jackson, P.; Borman, P.; Campa, C.; Chatfield, M.; Godfrey, M.; Hamilton, P.; Hoyer, W.; Norelli, F.; Orr, R.; Schofield, T. Using the analytical target profile to drive the analytical method lifecycle. Anal. Chem., 2019, 91(4), 2577-2585.
[http://dx.doi.org/10.1021/acs.analchem.8b04596] [PMID: 30624912]
[39]
Ellwanger, J.B.; Wingert, N.R.; Volpato, N.M.; Garcia, C.V.; Schapoval, E.E.S.; Steppe, M. Analytical quality by design approach for a stability-indicating method to determine apixaban and its related impurities. Chromatographia, 2020, 83(1), 65-75.
[http://dx.doi.org/10.1007/s10337-019-03815-9]
[40]
Sarwar, B.M.S.H.; Mahfoozur, R.; Waleed, H.A. Handbook of Analytical Quality by Design, 1st ed; Academic Press, Elsevier, 2021.
[41]
Tome, T.; Časar, Z.; Obreza, A. Development of a unified reversed-phase hplc method for efficient determination of EP and USP process-related impurities in celecoxib using analytical quality by design principles. Molecules, 2020, 25(4), 809.
[http://dx.doi.org/10.3390/molecules25040809] [PMID: 32069880]
[42]
Rozet, E.; Lebrun, P.; Hubert, P.; Debrus, B.; Boulanger, B. Design Spaces for analytical methods. Trends Analyt. Chem., 2013, 42, 157-167.
[http://dx.doi.org/10.1016/j.trac.2012.09.007]
[43]
Vogt, F.G.; Kord, A.S. Development of quality-by-design analytical methods. J. Pharm. Sci., 2011, 100(3), 797-812.
[http://dx.doi.org/10.1002/jps.22325] [PMID: 21280050]
[44]
Orlandini, S.; Pinzauti, S.; Furlanetto, S. Application of quality by design to the development of analytical separation methods. Anal. Bioanal. Chem., 2013, 405(2-3), 443-450.
[http://dx.doi.org/10.1007/s00216-012-6302-2] [PMID: 22941176]
[45]
Chaudhari, S.R.; Shirkhedkar, A.A. Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation. J. Anal. Sci. Technol., 2019, 10(1), 10.
[http://dx.doi.org/10.1186/s40543-019-0170-8]
[46]
Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report; U.S. Food and Drug Administration, 2004.
[47]
Guidance for Industry PAT- A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; Food and Drug Administration, 2004.
[48]
Questions and answers: Improving the understanding of NORs, PARs, DSp and normal variability of process parameters; European Medicines Agency, 2017.
[49]
Sharma, T.; Jain, A.; Saini, S.; Katare, O.P.; Singh, B. Implementation of analytical quality‐by‐design and green analytical chemistry approaches for the development of robust and ecofriendly UHPLC analytical method for quantification of chrysin. Separ. Sci. Plus, 2020, 3(9), 384-398.
[http://dx.doi.org/10.1002/sscp.202000028]
[50]
Jayagopal, B.; Shivashankar, M. Analytical quality by design–a legitimate paradigm for pharmaceutical analytical method development and validation. Mech. mater. sci. eng., 2017, 2412-5954.
[51]
Traple, M.A.L.; Saviano, A.M.; Francisco, F.L.; Lourenço, F.R. Measurement uncertainty in pharmaceutical analysis and its application. J. Pharm. Anal., 2014, 4(1), 1-5.
[http://dx.doi.org/10.1016/j.jpha.2013.11.001] [PMID: 29403863]
[52]
van Leeuwen, J.F.; Nauta, M.J.; de Kaste, D.; Odekerken-Rombouts, Y.M.C.F.; Oldenhof, M.T.; Vredenbregt, M.J.; Barends, D.M. Risk analysis by FMEA as an element of analytical validation. J. Pharm. Biomed. Anal., 2009, 50(5), 1085-1087.
[http://dx.doi.org/10.1016/j.jpba.2009.06.049] [PMID: 19640668]
[53]
Aven, T. Risk assessment and risk management: Review of recent advances on their foundation. Eur. J. Oper. Res., 2016, 253(1), 1-13.
[http://dx.doi.org/10.1016/j.ejor.2015.12.023]
[54]
Kiran, D. Failure modes and effects analysis; Google Scholar, 2017, pp. 373-389.
[55]
Pyzdek, T. Pareto analysis. In: The Lean Healthcare Handbook, 2nd ed; Springer, 2021; pp. 157-164.
[http://dx.doi.org/10.1007/978-3-030-69901-7_14]
[56]
Zhang, X.; Hu, C. Application of quality by design concept to develop a dual gradient elution stability-indicating method for cloxacillin forced degradation studies using combined mixture-process variable models. J. Chromatogr. A, 2017, 1514, 44-53.
[http://dx.doi.org/10.1016/j.chroma.2017.07.062] [PMID: 28760604]
[57]
Barnet, K.; McGregor, P.; Martin, G.; LeBlond, D.; Weitzel, M.; Ermer, J.; Walfish, S.; Nethercote, P.; Gratzl, G.; Kovacs, E. In analytical target profile: Structure and application throughout the analytical lifecycle. Pharmacop. Forum, 2017, 42(5)
[58]
Ameeduzzafar; El-Bagory, I.; Alruwaili, N.K.; Imam, S.S.; Alomar, F.A.; Elkomy, M.H.; Ahmad, N.; Elmowafy, M. Quality by design (QbD) based development and validation of bioanalytical RP-HPLC method for dapagliflozin: Forced degradation and preclinical pharmacokinetic study. J. Liq. Chromatogr. Relat. Technol., 2020, 43(1-2), 53-65.
[http://dx.doi.org/10.1080/10826076.2019.1667820]
[59]
Solanki, A.B.; Parikh, J.R.; Parikh, R.H. Formulation and optimization of piroxicam proniosomes by 3-factor, 3-level box-behnken design. AAPS PharmSciTech, 2007, 8(4), 43.
[http://dx.doi.org/10.1208/pt0804086] [PMID: 18181547]
[60]
Khairnar, G.; Naik, J.; Mokale, V. A statistical study on the development of micro particulate sustained drug delivery system for Losartan potassium by 3 2 factorial design approach. Bull. Fac. Pharm. Cairo Univ., 2017, 55(1), 19-29.
[http://dx.doi.org/10.1016/j.bfopcu.2016.10.001]
[61]
Abou-Taleb, H.N.; El-Enany, M.N.; El-Sherbiny, T.D.; El-Subbagh, I.H. Digitally enhanced thin layer chromatography for simultaneous determination of norfloxacin and tinidazole with the aid of Taguchi orthogonal array and desirability function approach: Greenness assessment by analytical Eco‐Scale. J. Sep. Sci., 2020, 43(6), 1195-1202.
[http://dx.doi.org/10.1002/jssc.201900997] [PMID: 31860164]
[62]
Mašković, M.; Jančić-Stojanović, B.; Malenović, A.; Ivanović, D.; Medenica, M. Assessment of liquid chromatographic method robustness by use of Plackett-Burman design. Acta Chromatogr., 2010, 22(2), 281-296.
[http://dx.doi.org/10.1556/AChrom.22.2010.2.10]
[63]
Kumar, L.; Sreenivasa Reddy, M.; Managuli, R.S.; Pai K, G. Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles. Saudi Pharm. J., 2015, 23(5), 549-555.
[http://dx.doi.org/10.1016/j.jsps.2015.02.001] [PMID: 26594122]
[64]
Aydar, A.Y. Utilization of response surface methodology in optimization of extraction of plant materials. In: Statistical approaches with emphasis on design of experiments applied to chemical processes; intechopen, 2018; pp. 157-169.
[65]
Czyrski, A.; Sznura, J. The application of Box-Behnken-Design in the optimization of HPLC separation of fluoroquinolones. Sci. Rep., 2019, 9(1), 19458.
[http://dx.doi.org/10.1038/s41598-019-55761-z] [PMID: 31857613]
[66]
Owolabi, R.U.; Usman, M.A.; Kehinde, A.J. Modelling and optimization of process variables for the solution polymerization of styrene using response surface methodology. J. King Saud Univ. Eng. Sci., 2018, 30(1), 22-30.
[http://dx.doi.org/10.1016/j.jksues.2015.12.005]
[67]
Bayuo, J.; Abukari, M.A.; Pelig-Ba, K.B. Optimization using central composite design (CCD) of response surface methodology (RSM) for biosorption of hexavalent chromium from aqueous media. Appl. Water Sci., 2020, 10(6), 135.
[http://dx.doi.org/10.1007/s13201-020-01213-3]
[68]
Stat-Ease. Design Expert. Minneapolis. Available from: https://www.statease.com/
[69]
Myers, R.H.; Montgomery, D.C.; Anderson-Cook, C.M. Response Surface Methodology: Process and Product Optimization Using Designed Experiments; John Wiley & Sons, 2016.
[70]
Nethercote, P.; Borman, P.; Bennett, T.; Martin, G.; McGregor, P. QbD for better method validation and transfer. Pharm. Manu., 2010, 9(4)
[71]
Analytical Data- Interpretation and Treatment; U.S. Pharmacopeia, 2012, pp. 436-447.

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy