Generic placeholder image

Current Indian Science

Editor-in-Chief

ISSN (Print): 2210-299X
ISSN (Online): 2210-3007

Review Article

An Exhaustive Review on Recent Trends in Analytical Methods: Development Strategies and Recent Applications

Author(s): Tanu Chaudhary, Akshay Kumar, Naman Deep Raj, GS Sarma, Shubham Dawange and Dilpreet Singh*

Volume 2, 2024

Published on: 13 December, 2023

Article ID: e2210299X246468 Pages: 14

DOI: 10.2174/012210299X246468231115051717

Price: $

Abstract

API analysis plays an important role in nourishing the quality, safety, efficacy, and potency of bulk drugs and pharmaceutical formulations. Increased drug products in the market lead to increased demand for new analytical techniques for Active Pharmaceutical Ingredient (API) analysis. During the past decades, method developments were necessitated for drug impurities, excipient profiling, and testing for biopharmaceuticals like dissolution and bioavailability. Moreover, advancements in the pharmaceutical industries necessitate upgrading newer technologies like analytical Quality by Design (QbD) and artificial intelligence. This review focused on analytical method development and its official guidelines provided by various regulatory bodies including ICH, US-FDA, AOAC, and USP. Moreover, this present art also states various validation and system parameters along with their applicability and recommended range. The critical appraisal of analytical technologies for performing various API analyses was also written in a scientific manner. Moreover, applications in recent trends in pharmaceutical industries as well as research were also documented. Hence, this review provides sufficient information for the readers for in-depth information starting from scratch to higher technologies for developing analytical methods and recent trends in the pharmaceutical industry.

[1]
Siddiqui, M.R.; AlOthman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem., 2017, 10, S1409-S1421.
[http://dx.doi.org/10.1016/j.arabjc.2013.04.016]
[2]
Khan, I.; Iqbal, Z.; Khan, A.; Hassan, M.; Nasir, F.; Raza, A.; Ahmad, L.; Khan, A.; Akhlaq Mughal, M. A simple, rapid and sensitive RP-HPLC-UV method for the simultaneous determination of sorafenib & paclitaxel in plasma and pharmaceutical dosage forms: Application to pharmacokinetic study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2016, 1033-1034, 261-270.
[http://dx.doi.org/10.1016/j.jchromb.2016.08.029] [PMID: 27592284]
[3]
Mendez, A.S.L.; Steppe, M.; Schapoval, E.E.S. Validation of HPLC and UV spectrophotometric methods for the determination of meropenem in pharmaceutical dosage form. J. Pharm. Biomed. Anal., 2003, 33(5), 947-954.
[http://dx.doi.org/10.1016/S0731-7085(03)00366-2] [PMID: 14656585]
[4]
Begas, E.; Papandreou, C.; Tsakalof, A.; Daliani, D.; Papatsibas, G.; Asprodini, E. Simple and reliable HPLC method for the monitoring of methotrexate in osteosarcoma patients. J. Chromatogr. Sci., 2014, 52(7), 590-595.
[http://dx.doi.org/10.1093/chromsci/bmt081] [PMID: 23800772]
[5]
Munro, G. ICH Q7 good manufacturing practice guide for active pharmaceutical ingredients [APIs]. In: ICH Qual Guidel; , 2017; pp. 509-534.
[http://dx.doi.org/10.1002/9781118971147.ch19]
[6]
Reddy, V.; Thiruvengada, V.; Amruth, N. A review on analytical method validation. Int J Rev Life Sci., 2011, 1(3), 141-144.
[7]
Taverniers, I.; De Loose, M.; Van Bockstaele, E. Trends in quality in the analytical laboratory. II. analytical method validation and quality assurance. Trends Analyt. Chem., 2004, 23(8), 535-552.
[http://dx.doi.org/10.1016/j.trac.2004.04.001]
[8]
Breaux, J.; Jones, K.; Boulas, P. Analytical methods development and validation. Pharm. Technol., 2003, 1, 6-13.
[9]
Green, J.M. Peer reviewed: A practical guide to analytical method validation. Anal. Chem., 1996, 68(9), 305A-309A.
[http://dx.doi.org/10.1021/ac961912f]
[10]
DiMasi, J.A.; Hansen, R.W.; Grabowski, H.G.; Lasagna, L. Cost of innovation in the pharmaceutical industry. J. Health Econ., 1991, 10(2), 107-142.
[http://dx.doi.org/10.1016/0167-6296(91)90001-4] [PMID: 10113009]
[11]
Haftka, R.T.; Gürdal, Z. Elements of structural optimization; Springer Science & Business Media, 2012, 11, .
[12]
Afsah-Hejri, L.; Jinap, S.; Arzandeh, S.; Mirhosseini, H. Optimization of HPLC conditions for quantitative analysis of aflatoxins in contaminated peanut. Food Control, 2011, 22(3-4), 381-388.
[http://dx.doi.org/10.1016/j.foodcont.2010.09.007]
[13]
Ermer, J. Validation in pharmaceutical analysis. Part I: An integrated approach. J. Pharm. Biomed. Anal., 2001, 24(5-6), 755-767.
[http://dx.doi.org/10.1016/S0731-7085(00)00530-6] [PMID: 11248468]
[14]
Sharma, S.; Goyal, S.; Chauhan, K. A review on analytical method development and validation. International Journal of Applied Pharmaceutics, 2018, 10(6), 8-15.
[http://dx.doi.org/10.22159/ijap.2018v10i6.28279]
[15]
Burgess, C. Valid analytical methods and procedures. In: Royal Society of Chemistry; , 2000.
[http://dx.doi.org/10.1039/9781847552280]
[16]
Wood, R. How to validate analytical methods à, à. 1999, 18, 624-632.
[http://dx.doi.org/10.1016/S0165-9936(99)00150-8]
[17]
Reinhard, M.; Drefahl, A. Handbook for estimating physicochemical properties of organic compounds; New York, 1999, p. 39.
[18]
Aruna, D. Research and reviews: Journal of pharmaceutical analysis method development and validation parameters of UV-. Commentary, 2015, 4(3), 1-10.
[19]
Minchin, R.E., Jr; Smith, G.R. Quality-based contractor rating model for qualification and bidding purposes. J. Manage. Eng., 2005, 21(1), 38-43.
[http://dx.doi.org/10.1061/(ASCE)0742-597X(2005)21:1(38)]
[20]
Riley, CM; Rosanske, TW Development and validation of analytical methods. 1996, May 29.
[21]
Agnihotri, A.; Kaur, S.; Kumar, J.; Chahal, R. Performance qualification: Critical to validation. Asian J. Transfus. Sci., 2013, 7(1), 4-5.
[http://dx.doi.org/10.4103/0973-6247.106711] [PMID: 23559754]
[22]
Yue, L.; Niu, P.; Wang, Y. Guidelines for defining user requirement specifications [URS] of manufacturing execution system [MES] based on ISA-95 standard. In: Journal of Physics: Conference Series ; , 2019; 1168, p. Feb 1(3)032065.
[23]
Chan, CC Analytical method validation: principles and practices. Pharmaceutical Manufacturing Handbook: Regulations and Quality, 2008, 727-742.
[http://dx.doi.org/10.1002/9780470259832.ch22]
[24]
Ravisankar, P.; Naga Navya, C.; Pravallika, D.; Sri, D.N. A review on step-by-step analytical method validation. IOSR J. Pharm., 2015, 5(10), 2250-3013.
[25]
Comments, D.F.O.R. Guideliness on validation – appendix 6 validation of qualification of systems. Utilities and equipment Pqt Inspections., 2016, (June), 1-36.
[26]
Bruce, P.; Minkkinen, P.; Riekkola, M. Practical Method Validation. Validation Sufficient for an Analysis Method., 1998, 106, 93-106.
[27]
Naik, N.K.; Ganesh, V.K. An analytical method for plain weave fabric composites. Composites, 1995, 26(4), 281-289.
[http://dx.doi.org/10.1016/0010-4361(95)93671-6]
[28]
Development, F. Comparison of various international guidelines for analytical method validation. 2007, 62 [Green 1996].
[29]
Araujo, P. Key aspects of analytical method validation and linearity evaluation. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2009, 877(23), 2224-2234.
[http://dx.doi.org/10.1016/j.jchromb.2008.09.030] [PMID: 18929516]
[30]
Kollipara, S.; Bende, G.; Agarwal, N.; Varshney, B.; Paliwal, J. International guidelines for bioanalytical method validation: A comparison and discussion on current scenario. Chromatographia, 2011, 73(3-4), 201-217.
[http://dx.doi.org/10.1007/s10337-010-1869-2]
[31]
Kadian, N.; Raju, K.S.R.; Rashid, M.; Malik, M.Y.; Taneja, I.; Wahajuddin, M. Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry. J. Pharm. Biomed. Anal., 2016, 126, 83-97.
[http://dx.doi.org/10.1016/j.jpba.2016.03.052] [PMID: 27179186]
[32]
Shabir, G.A.; John Lough, W.; Arain, S.A.; Bradshaw, T.K. Evaluation and application of best practice in analytical method validation. J. Liq. Chromatogr. Relat. Technol., 2007, 30(3), 311-333.
[http://dx.doi.org/10.1080/10826070601084753]
[33]
Guideline, IH Validation of analytical procedures: text and methodology. Q2 [R1]. 2005, Nov;1(20), 05.
[34]
Ferraz, L.S.; Gabbay, D.M.; Economides, K.; Almeida, F.; de Araujo Asperti, M.C.; Chasin, A.C.; da Costa, S.H.; Gross Cunha, L.; Lauris, E.; Takahashi, B. Round table: Rethinking access to justice: Old problems, new challenges. Braz. J. Empirical Legal Stud., 2017, 4, 174.
[35]
Shabir, G.A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the us food and drug administration, the US pharmacopeia and the international conference on harmonization. J. Chromatogr. A, 2003, 987(1-2), 57-66.
[http://dx.doi.org/10.1016/S0021-9673(02)01536-4] [PMID: 12613797]
[36]
Agency, EM European Medicines Agency. Definitions., 2020, 2, 1-15.
[37]
Conference, I; Harmonisation, ON; Technical, OF; For, R; Of, R; For, P Ich H Armonised T Ripartite G Uideline P Harmacokinetics : S3B. 1994, 1994
[38]
Verbić, T.; Dorkó, Z.; Horvai, G. Selectivity in analytical chemistry. Rev. Roum. Chim., 2013, 58(7–8), 569-575.
[39]
Gustavo González, A.; Ángeles Herrador, M. A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles. Trends Analyt. Chem., 2007, 26(3), 227-238.
[http://dx.doi.org/10.1016/j.trac.2007.01.009]
[40]
Peters, F.T.; Drummer, O.H.; Musshoff, F. Validation of new methods. Forensic Sci. Int., 2007, 165(2-3), 216-224.
[http://dx.doi.org/10.1016/j.forsciint.2006.05.021] [PMID: 16781833]
[41]
Sharma, K.; Agrawal, S.S.; Gupta, M. Development and validation of UV spectrophotometric method for the estimation of curcumin in bulk drug and pharmaceutical dosage forms. Int J Drug Dev Res., 2012, 4(2), 375-380.
[42]
Sengoku, T.; Morita, K.; Sakuma, S.; Motoyama, Y.; Goto, T. Possible inhibitory mechanism of FK506 [tacrolimus hydrate] ointment for atopic dermatitis based on animal models. In: European Journal of Pharmacology; , 1999; 379, pp. 183-189.
[43]
Validation of Analytical Methods: Methodology. Ich Q2B. 1996, 53, 128-143.
[44]
Chang, H.H.; Huang, W.C. Application of a quantification SWOT analytical method. Math. Comput. Model., 2006, 43(1-2), 158-169.
[http://dx.doi.org/10.1016/j.mcm.2005.08.016]
[45]
Green, B.C.; Support, N.R. A Step-by-Step Approach Method Validation Program. In: Anal Method Valid; , 1990.
[46]
Carr, G.P.; Wahlich, J.C. A practical approach to method validation in pharmaceutical analysis. J. Pharm. Biomed. Anal., 1990, 8(8-12), 613-618.
[http://dx.doi.org/10.1016/0731-7085(90)80090-C] [PMID: 2100596]
[47]
Rozet, E; Ceccato, A; Ziemons, E; Oprean, R; Rudaz, S; Boulanger, B Analysis of recent pharmaceutical regulatory documents on analytical method validation. 2007, 1158, 111-125.
[http://dx.doi.org/10.1016/j.chroma.2007.03.111]
[48]
Jenke, DR Journal of Liquid Chromatography & Related Technologies Chromatographic Method Validation : A Review of Current Practices and Procedures.II . Guidelines for Primary Validation Parameters., [November 2012], 37-41.
[49]
Stöckl, D; Hondt, HD; Thienpont, LM Method validation across the disciplines — critical investigation of major validation criteria and associated experimental protocols ଝ. 2009, 877, 2180-2190.
[50]
Chikanbanjar, N; Semwal, N; Jyakhwa, U. A Review Article on Analytical Method Validation. 2020. ;[November].
[51]
De Meyer, D.; Amalraj, A.; Van Limbergen, T.; Fockedey, M.; Edwards, S.; Moustsen, V.A.; Chantziaras, I.; Maes, D. Short communication: Effect of positive handling of sows on litter performance and pre-weaning piglet mortality. Animal, 2020, 14(8), 1733-1739.
[http://dx.doi.org/10.1017/S1751731120000427] [PMID: 32178758]
[52]
Taylor, P; Konieczka, P; Konieczka, P. Critical reviews in analytical chemistry the role of and the place of method validation in the quality assurance and quality control [ QA / QC ] system the role of and the place of method validation in the quality assurance and quality control [ QA / QC ] system. 2007[December 2014]:, 37-41.
[53]
Ravisankar, P; Gowthami, S; Rao, GD A review on analytical method development 1. 2014, 5674, 1183-1195. [June]
[54]
Heyden, Y; Vander; Nijhuis, A; Smeyers-verbeke, J. Guidance for robustness / ruggedness tests in method validation. 2001, 24, 723-753.
[55]
Nijhuis, A; Knaap, HCM; Van Der; Jong, S; De; Vandeginste, BGM Strategy for ruggedness tests in chromatographic method validation. 1999, 391.
[http://dx.doi.org/10.1016/S0003-2670(99)00113-0]

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