Modern Trends in Analytical Techniques for Method Development and Validation of Pharmaceuticals: A Review

  • Shivani Sharma Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India
  • Navdeep Singh Department of Pharmaceutics, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India
  • Amar Deep Ankalgi Professor and Head of Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India
  • Arti Rana Assistant Professor, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India
  • Mahendra Singh Ashawat Principal cum Director, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Abstract

The process of drug development requires a suitable technique which helps the scientist to analyze the drug molecule is an accurate, precise, and easiest way. For the quantitative and qualitative estimation of drugs in analytical chemistry it is very important to identify the best method for method development.  This study helps the author to understand the various analytical techniques available for the process of drug development which includes spectroscopy, chromatography, electrochemical techniques, electrophoretic, flow injection analysis, and hyphenated technique. All these methods contain different analytical process with a variety of separate techniques. Also, we discuss about the modern trend which are available, and implacable in all these methods to improve the analytical behavior of these techniques. In method development process the validation of document must be required in the form of accuracy, precision, specificity, limit of detection, linearity, and range is considered. So, this review article contains the brief summary of available analytical techniques, and the latest trend in method development, or the process of method validation, and development of method. The discussed methods in this review article were revealed by the scientist, and these techniques must require in new drug development process, which helps the person to utilize the potential of these techniques. Trend in the analytical chemistry to overcome the error in method development was necessary, and the latest trends in method development technique were useful to defeat errors in analytical techniques.


Keywords: Analytical techniques, Modern trends, Process of method development, and validation.

Keywords: Analytical techniques, Modern trends, Process of method development, validation

Downloads

Download data is not yet available.

Author Biographies

Shivani Sharma, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Navdeep Singh, Department of Pharmaceutics, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Department of Pharmaceutics, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Amar Deep Ankalgi, Professor and Head of Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Professor and Head of Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Arti Rana, Assistant Professor, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Assistant Professor, Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Mahendra Singh Ashawat, Principal cum Director, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

Principal cum Director, Laureate Institute of Pharmacy, Kathog, Jawalamukhi, Himachal Pradesh 176031, India

References

1. Kupiec T. Quality-control analytical methods: High-performance liquid chromatography. International journal of pharmaceutical compounding. 2004; 8:223-7.
2. Siddiqui MR, AlOthman ZA, Rahman N. Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of chemistry. 2017; 10:S1409-21.
3. Anderson DJ. High-performance liquid chromatography in clinical analysis. Analytical chemistry. 1999; 71(12):314-27.
4. Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm. 2015; 5(10):7-19.
5. Lal B, Kapoor D, Jaimini M. A review on analytical method validation and its regulatory perspectives. Journal of Drug Delivery and Therapeutics. 2019; 9(2):501-6.
6. Ramana Rao G, Murthy SS, Khadgapathi P. High performance liquid chromatography and its role in pharmaceutical analysis. Eastern Pharmacist. 1986; 29(346):53.
7. Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. Journal of pharmaceutical and biomedical analysis. 1990; 8(8-12):613-8.
8. Jatto E, Okhamafe AO. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research. 2002; 1(2):115-22.
9. Al-Akkam EJ. Applying of a modified and validated high-performance liquid chromatographic/ultraviolet method for quantification of cetirizine in human plasma for pharmacokinetics studies. Drug Invention Today. 2020; 14(1).
10. Chauhan A, Mittu B, Chauhan P. Analytical method development and validation: a concise review. J Anal Bioanal Tech. 2015; 6(1):5.
11. Lacrok PM, Curran NM, Sy WW, Goreck DK, Thibault P, Blay PK. Liquid chromatographic determination of amiodarone hydrochloride and related compounds in raw materials and tablets. Journal of AOAC International. 1994; 77(6):1447-53.
12. Thyagarajapuram N, Alexander KS. A simplified method for the estimation of amiodarone hydrochloride by reverse‐phase high performance liquid chromatography. Journal of liquid chromatography & related technologies. 2003; 26(8):1315-26.
13. Christopherson MJ, Yoder KJ, Miller RB. Validation of a Stability‐Indicating HPLC Method for the Determination of Amiodarone HCl and Its Related Substances in Amiodarone HCl Injection. Journal of liquid chromatography & related technologies. 2004; 27(1):95-111.
14. Sistla R, Tata VS, Kashyap YV, Chandrasekar D, Diwan PV. Development and validation of a reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms. Journal of pharmaceutical and biomedical analysis. 2005; 39(3-4):517-22.
15. Kumar DA, Sujan DP, Vijayasree V, Rao JV. Simultaneous determination of simvastatin and ezetimibe in tablets by HPLC. E-journal of chemistry. 2009; 6.
16. Vishwanathan K, Bartlett MG, Stewart JT. Determination of gatifloxacin in human plasma by liquid chromatography/electrospray tandem mass spectrometry. Rapid Communications in Mass Spectrometry. 2001; 15(12):915-9.
17. Elbarbry FA, Mabrouk MM, El-Dway MA, Determination of the analgesic components of Spasmomigraine tablet by liquid chromatography with ultraviolet detection. J AOAC Int 2007; 90:94-101.
18. Sethi PD, Charegaonkar D, editors. Identification of drugs in pharmaceutical formulations by thin layer chromatography. CBS Publishers; 1999.
19. Singh RK, Rathnam MV, Singh SJ, Vegesna RV. Determination of Camylofin dihydrochloride and Nimesulide in Pharmaceutical preparation by Gas chromatography. American Journal of Analytical Chemistry. 2011; 2(8):944.
20. Natesan S, Thanasekaran D, Krishnaswami V, Ponnusamy C. Improved RP-HPLC method for the simultaneous estimation of tranexamic acid and mefenamic acid in tablet dosage form. Pharm. Anal. Acta. 2011; 2(1):115.
21. Puozzo C, Filaquier C, Zorza G. Determination of milnacipran, a serotonin and noradrenaline reuptake inhibitor, in human plasma using liquid chromatography with spectrofluorimetric detection. Journal of Chromatography B. 2004; 806(2):221-8.
22. Shinozuka T, Terada M, Tanaka E. Solid-phase extraction and analysis of 20 antidepressant drugs in human plasma by LC/MS with SSI method. Forensic science international. 2006; 162(1-3):108-12.
23. Zhang LJ, Yao YM, Sun JJ, Chen J, Jia XF. An LC–MS/MS Method for Simultaneous Quantification of Seven Anti-HIV Medicines in Plasma of HIV-infected Patients. Pharm Anal Acta. 2010; 1(1):1.
24. Rajender G, Narayana NG. Liquid Chromatography-Tandem Mass Spectrometry Method for Determination of Paclitaxel in Human Plasma. Pharm Anal Acta. 2010; 1:101.
25. Sharma HK, Jain N, Jain SK. Development of spectrophotometric method for quantitative estimation of Amlodipine besylate, olmesartan medoxomil and hydrochlorthiazide in tablet dosage form. Pharm Anal Acta. 2011; 2(126):2.
26. Chen P, Atkinson R, Wolf WR. Single-laboratory validation of a high-performance liquid chromatographic-diode array detector-fluorescence detector/mass spectrometric method for simultaneous determination of water-soluble vitamins in multivitamin dietary tablets. Journal of AOAC International. 2009; 92(2):680-8.
27. Schellens JH, Meerum Terwogt JM, Ten Bokkel Huinink WW, Rosing H, Van Tellingen O, Swart M, Duchin KL, Beijnen JH. Cyclosporin A (CsA) strongly enhances oral bioavailability of paclitaxel (pac) in cancer patients. InProc Am Soc Clin Oncol 1998 (Vol. 17, p. 186a).
28. Sharma A, Conway WD, Straubinger RM. Reversed-phase high-performance liquid chromatographic determination of taxol in mouse plasma. Journal of Chromatography B: Biomedical Sciences and Applications. 1994; 655(2):315-9.
29. Singh N, Goyal K, Sondhi S, Jindal S. Development and Characterization of Barbaloin Gel for the Safe and Effective Treatment of Psoriasis. Journal of Drug Delivery and Therapeutics. 2020; 10(5):188-97.
30. Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Jirathitikal V, Bourinbaiar AS. Phase 2 trial of V-5 Immunitor (V5) in patients with chronic hepatitis C co-infected with HIV and Mycobacterium tuberculosis. Journal of Vaccines and Vaccination. 2010; 1(1).
31. Nannan Panday VR, Meerum Terwot JM, Ten Bokkel Huinink WW. The role of pro drug therapy in the treatment of cancer. InProc Am Soc Clin Oncol 1998 (Vol. 17, p. 742a).
32. Georgiou CA, Valsami GN, Macheras PE, Koupparis MA. Automated flow-injection technique for use in dissolution studies of sustained-release formulations: application to iron (II) formulations. Journal of pharmaceutical and biomedical analysis. 1994; 12(5):635-41.
33. Hauck WW, Anderson S. Types of bioequivalence and related statistical considerations. International Journal of Clinical Pharmacology, Therapy, and Toxicology. 1992; 30(5):181-7.
34. Khandave SS, Joshi SS, Sawant SV, Onkar SV. Evaluation of Bioequivalence and Cardio-Hepatic Safety of a Single Dose of Fixed Dose Combination of Artemether and Lumefantrine. J Bioequiv Availab 2:081-085.
35. Gul W. Metformin: methods of analysis and its role in lowering the risk of cancer. J Bioequiv Availab. 2016; 8:254-9.
36. Mahapatra L, Sahoo GR, Panda MK, Parija S. Pharmacokinetic profile of nimesulide in bovine calves. Journal of Bioequivalence & Bioavailability. 2009; 1:121-.
37. Moreno RA, Sverdloff CE, Oliveira RA, Oliveira SE, Borges DC. Comparative bioavailability and pharmacodynamic aspects of cyclobenzaprine and caffeine in healthy subjects and the effect on drowsiness intensity. J Bioequiv Availab. 2009; 1:086-92.
38. Singh N, Goyal K, Sondhi S, Jindal S. Traditional and medicinal use of Barbaloin: potential for the management of various diseases. Journal of Applied Pharmaceutical Research. 2020; 8(3):21-30.
39. Najib NM, Salem I, Hasan R, Idkaidek NM. Effect of truncated AUC method on drug bioequivalence in humans. J Bioequiv Availab. 2009; 1:112-4.
40. Shah D, Nandakumar S, Jaishankar GB, Chilakala S, Wang K, Kumaraguru U. Pre-Term Exposure Patterns in Neonatal Intensive Care Unit Alters Immunological Outcome in Neonates. J Aller Ther. 2011; 2(7).
41. Swartz ME, Krull IS, editors. Analytical method development and validation. CRC Press; 2018 Oct 3.
42. Singh R. HPLC method development and validation-an overview. Journal of Pharmaceutical Education & Research. 2013; 4(1).
43. Breaux J, Jones K, Boulas P. Analytical methods development and validation. Pharm. Technol. 2003; 1:6-13.
44. Grubbs FE. Errors of measurement, precision, accuracy and the statistical comparison of measuring instruments. Technometrics. 1973; 15(1):53-66.
45. Karnes HT, March C. Precision, accuracy, and data acceptance criteria in biopharmaceutical analysis. Pharmaceutical research. 1993; 10(10):1420-6.
46. Naz S, Vallejo M, García A, Barbas C. Method validation strategies involved in non-targeted metabolomics. Journal of Chromatography A. 2014; 1353:99-105.
47. Garsuch V, Breitkreutz J. Novel analytical methods for the characterization of oral wafers. European Journal of Pharmaceutics and Biopharmaceutics. 2009; 73(1):195-201.
48. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. John Wiley & Sons; 2012 Dec 3.
49. Hema SR. A Review On New Analytical Method Development And Validation By Rp-HPLC. Int Res J Pharm Biosci. 2017; 4:41-50.
50. Kumar DA, Sujan DP, Vijayasree V, Rao JV. Simultaneous determination of simvastatin and ezetimibe in tablets by HPLC. E-journal of chemistry. 2009; 6.
51. Gupta V, Jain AD, Gill NS, Guptan K. Development and validation of HPLC method-a review. International research journal of pharmaceutical and applied sciences. 2012; 2(4):17-25.
52. Bhardwaj SK, Dwivedia K, Agarwala DD. A review: HPLC method development and validation. International Journal of Analytical and Bioanalytical Chemistry. 2015; 5(4):76-81.
53. Zakeri-Milani P, Barzegar-Jalali M, Tajerzadeh H, Azarmi Y, Valizadeh H. Simultaneous determination of naproxen, ketoprofen and phenol red in samples from rat intestinal permeability studies: HPLC method development and validation. Journal of pharmaceutical and biomedical analysis. 2005; 39(3-4):624-30.
54. Jain V, Shah VK, Jain PK. HPLC method development and validation for the estimation of esomeprazole in bulk and pharmaceutical dosage form. Journal of Drug Delivery and Therapeutics. 2019; 9(4):292-5.
55. Çelebier M, Reçber T, Koçak E, Altinöz S. RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. Brazilian Journal of Pharmaceutical Sciences. 2013; 49(2):359-66.
56. Pharne AB, Santhakumari B, Ghemud AS, Jain HK, Kulkarni MJ. Bioanalytical method development and validation of vildagliptin a novel dipeptidyl peptidase IV inhibitor by RP-HPLC method. International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(3):119-23.
57. Taverniers I, Van Bockstaele E, De Loose M. Analytical method validation and quality assurance. Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing. 2010:1-48.
58. Green JM. Peer reviewed: a practical guide to analytical method validation. Analytical chemistry. 1996; 68(9):305A-9A.
59. Araujo P. Key aspects of analytical method validation and linearity evaluation. Journal of chromatography B. 2008; 877(23):2224-34.
60. Magnusson B. The fitness for purpose of analytical methods: a laboratory guide to method validation and related topics (2014).
61. Shabir GA, John Lough W, Arain SA, Bradshaw TK. Evaluation and application of best practice in analytical method validation. Journal of liquid chromatography & related technologies. 2007; 30(3):311-33.
62. Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. Journal of pharmaceutical and biomedical analysis. 1990; 8(8-12):613-8.
63. Peters FT, Drummer OH, Musshoff F. Validation of new methods. Forensic science international. 2007; 165(2-3):216-24.
64. Bruce P, Minkkinen P, Riekkola ML. Practical method validation: validation sufficient for an analysis method. Microchimica Acta. 1998; 128(1-2):93-106.
65. Chandran S, Singh RS. Comparison of various international guidelines for analytical method validation. Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2007; 62(1):4-14.
66. Rozet E, Ceccato A, Hubert C, Ziemons E, Oprean R, Rudaz S, Boulanger B, Hubert P. Analysis of recent pharmaceutical regulatory documents on analytical method validation. Journal of Chromatography A. 2007; 1158(1-2):111-25.
Statistics
90 Views | 85 Downloads
How to Cite
1.
Sharma S, Singh N, Ankalgi AD, Rana A, Ashawat MS. Modern Trends in Analytical Techniques for Method Development and Validation of Pharmaceuticals: A Review. JDDT [Internet]. 15Feb.2021 [cited 23Apr.2021];11(1-s):121-30. Available from: http://www.jddtonline.info/index.php/jddt/article/view/4515