• A Comprehensive Review on Analytical Methods for The Estimation of Pharmaceuticals
  • Department of Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik-422102


A proper approach that enables the scientist to analyse the drug molecule in the most exact, precise, and simple manner is necessary for the process of developing new medications. Finding the optimum approach for method development is crucial for the quantitative and qualitative estimate of pharmaceuticals in analytical chemistry. This research aids the author in comprehending the many analytical methods that may be used in the drug development process, including spectroscopy, chromatography, electrochemical methods, electrophoretic analysis, flow injection, and hyphenated method. All of these strategies use several independent methodologies and distinct analytical processes. We also talk about the current, unwavering trends that may be applied to all of these procedures to enhance their analytical behaviour. The validation of the document in terms of accuracy, precision, specificity, limit of detection, linearity, and range is necessary during the method development phase. Thus, this review article includes a concise assessment of the analytical approaches that are now accessible as well as the most recent developments in method development, method validation, and method development. Several chemical and instrumental techniques that are used in drug estimation have been developed over time in order to make medications function as intended. These medications must be recognised and quantitated since contaminants can form in them at different points during production, transit, and storage, making administration dangerous. Analytical tools and techniques are crucial in this regard. In determining the quality of the medications, this study emphasises the importance of analytical procedures and equipment. The study covers many analytical methods that have been used in the examination of medicines, including titrimetric, chromatographic, spectroscopic, electrophoretic, and electrochemical.


Analytical methods, Method development, HPLC, TLC, spectroscopy


  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 stepby-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 highperformance 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. 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. 
  18. 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. 
  19. 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. 
  20. Rajender G, Narayana NG. Liquid Chromatography-Tandem Mass Spectrometry Method for Determination of Paclitaxel in Human Plasma. Pharm Anal Acta. 2010; 1:101. 
  21. 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. 
  22. Chen P, Atkinson R, Wolf WR. Single-laboratory validation of a high-performance liquid chromatographic-diode array detectorfluorescence detector/mass spectrometric method for simultaneous determination of water-soluble vitamins in multivitamin dietary tablets. Journal of AOAC International. 2009; 92(2):680-8. 
  23. 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). 
  24. Sharma A, Conway WD, Straubinger RM. Reversed-phase highperformance liquid chromatographic determination of taxol in mouse plasma. Journal of Chromatography B: Biomedical Sciences and Applications. 1994; 655(2):315-9. 
  25. 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. 
  26. 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). 
  27. 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). 
  28. 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 
  29. Hauck WW, Anderson S. Types of bioequivalence and related statistical considerations. International Journal of Clinical Pharmacology, Therapy, and Toxicology. 1992; 30(5):181-7. 
  30. 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. 
  31. Gul W. Metformin: methods of analysis and its role in lowering the risk of cancer. J Bioequiv Availab. 2016; 8:254-9. 
  32. Mahapatra L, Sahoo GR, Panda MK, Parija S. Pharmacokinetic profile of nimesulide in bovine calves. Journal of Bioequivalence & Bioavailability. 2009; 1:121
  33. Makridakis S, DiNicolantonio JJ. Hypertension: empirical evidence and implications. Heart Open.1.1 (1):000048, (2014).
  34. Chen R, Dharmarajan K, Kulkarni VT, Punnanithinont N, Gupta A, Bikdeli B, Mody PS, Ranasinghe I. Most important outcomes research papers on hypertension. Circulation: Cardiovascular Quality and Outcomes. 6(4):26-35, (2013). 
  35. Ma B, Prueksaritanont T, Lin JH. Drug interactions with calcium channel blockers: possible involvement of metabolite-intermediate complexation with CYP3A. Drug Metabolism and Disposition. 28(2):125-30, (2013). 
  36. Flynn JT, Pasko DA. Calcium channel blockers: pharmacology and place in therapy of pediatric hypertension. Pediatric Nephrology.15 (3-4):302-316, (2000). 
  37. The Merck Index, Merck and Co. New York.13: 937, (2001). 
  38. Nunez-Vergara LJ, Sunkel C, J. Pharm. Sci. 83.502-50, (1994). 
  39. Katz AM. Pharmacology and mechanisms of action of calcium-channel blockers. Journal of clinical hypertension. 2(3):28S-37S, (1986). 
  40. Fitton A, Benfield P. Isradipine. Drugs. 40(1):31-74, (1990).
  41. Hof RP, Scholtysik G, Loutzenhiser R, Vuorela HJ, Neumann P. PN 200110, A new calcium antagonist: electrophysiological, inotropic, and chronotropic effects on guinea pig myocardial tissue and effects on contraction and calcium uptake of rabbit aorta. Journal of cardiovascular pharmacology. 6(3):399-406, (1984). 
  42. Pharmacopoeia B. The Stationary Office Medicinal and Pharmaceutical Substances (A-I). London. I: 1091-1092, (2005). 
  43. The United State Pharmacopeia/The National Formulary. The Official Compendia of Standard, 27:1051-1052, (2004).
  44. Martindale Complete drug reference. An imprint of RPS Publishing pharmaceutical press. 35: 1319, (2007)
  45. Al-Ghannam SM, Al-Olyan AM. Spectrophotometric determination of nicradipine and isradipine in pharmaceutical formulations. Chemical Industry and Chemical Engineering Quarterly. 15(2):69-76, (2009). 
  46. Katariya H, Prajapati J. Development and validation of UV Spectrophotometric method for determination of isradipine loaded into solid lipid nanoparticles. International Journal of Pharmaceutical Sciences Review and Research. 20(2):162-166, (2013).
  47. Rao RN, Nagaraju P, Srinivasulu C, Radhakrishnamurthy P, Sireesha D, Bhaskar SU. UV Spectrophotometric methods for the determination of lercanidipine and isradipine in bulk and pharmaceutical formulations. Asian Journal of Chemistry. 16(3): 1950, (2004)

Krutanjali Nikumbh
Corresponding author

Department of Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik-422102

Kiran Dhamak

Department of Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik-422102

Krutanjali Nikumbh*, Kiran Dhamak, A Comprehensive Review on Analytical Methods for The Estimation of Pharmaceuticals, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 6, 65-77.

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