• Md. Sony Ahmed Sony Quality control officer
Keywords: Revolution, Identification, Impurities, chromatographic, spectroscopic


The development of drugs brought about a revolution in human health. Pharmaceuticals analytical techniques explain the process or various processes for the identification and quantification of a substance, the determination of the composition of pharmaceutical solution or mixtures or the composition of chemical compounds used in the production of pharmaceutical products. Different chemicals and instrumental methods were developed at regular intervals to enable the drugs to fulfill their purpose, which involved drug presumptions. The constituents observed include processed impurities, chiral drugs, residual solvents, degradation products, extractants as preservatives, extractable from the container, and the production process, drug product pesticides and metabolites from the plant source. Analytical instrumentation and methods play an important role in pharmaceuticals. The review covers a variety of analytical techniques such as titrimetric, particle size analysis, melting and boiling point, disintegration, dissolution, chromatographic (HPLC, GC-MS) and spectroscopic (IR, UV-Visible, AAS) methods that have been applied in the analysis of pharmaceuticals according to pharmacopoeias


1.Valagaleti, R., Burns, P.K., Michael Gill, Analytical Support for Drug Manufacturing in the United States—From Active Pharmaceutical Ingredient Synthesis to Drug Product Shelf Life. Drug Information Journal, 2003Volume: 37 issue: 4, page(s): 407-438

2 FDA’s Policy statement for the development of new stereoisomeric drugs, 1992. Chirality 4, pp. 338–340
3.Health Canada 2000, http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb- gpsa/pdf/

4.European Medicines Agency (1996), http://www.ema.europa.eu/docs /en GB/document library /Annual_report

5.ICH Topic Q 6 A., Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, 1999.

6. Akseli, I., Mani, G.N., Cetinkaya, C, Non-destructive acoustic defect detection in drug tablet. International Journal of Pharmaceutics 360 (2008) 65–76

7. Ivin Varghese, Cetin Cetinkaya ‘Noncontact photo-acoustic defect detection in drug tablets.
Journal of pharmaceutical sciences 2007 DOI:10.1002/jps.20838

8. Pajander J, Haugshøj KB, Bjørneboe K, Wahlberg P, Rantanen J. Foreign matter identification from solid dosage forms Journal of Pharmaceutical and Biomedical Analysis [05 Mar 2013, 80:116-125]
9.Pifferi, G., Santoro, P., Pedrani, M., Quality and functionality of excipients Farmaco, 1999 54 (1-20): p.14

10.U.S. Department Health and Human Services, 2003. Food and Drug Administration, Centre for drug evaluation and Research, Centre for Biologics Evaluation and Research. Guidance for Industry, Drug Product, Chemistry Manufacturing and Control Information, Draft Guidance, Rockville, Maryland, pp. 1–62.

11.U.S. Department Health and Human Services, 2002. Food and Drug Administration, Centre for drug evaluation and Research, Centre for Biologics Evaluation and Research. Draft Guidance for Industries, ‘‘Nonclinical studies for Development of Pharmaceutical Excipients’’, 2002, pp. 1–7.

12. Bryn, S.R., Xu, W., Newman, A ‘Chemical reactivity in solid-state pharmaceuticals: formulation implications. Adv Drug Deliv Rev. 2001 May 16;48(1):115-36.

13. Serajuddin, A.T.M., Thakur, A.B., Ghoshal, R.N., Fakes, M.G., Ranadive, S.A., Morris, K.R., Varia, S.A, ‘Selection of solid dosage form composition through drug-excipient compatibility testing. J Pharm Sci. 1999 Jul;88(7):696-704.

14. Matei, N., Birghila, S., Popescu, V., Dobrinas, S., Soceanu, A.,Oprea, C., Magearu, V . ‘Kinetic study of vitamin C degradation from pharmaceutical products. Rom. J. Phys 2008 343-351

15.Szepesi, G., Nyiredy, S, ‘Pharmaceutical and drugs. In: Sherma,J., Fried, B. (Eds.), Handbook of Thin-Layer Chromatography,2nd ed. Marcel Dekker, New York, 1996, pp. 208–235

16. White, D., Varlashkin, P., Rusch, D.N, ‘A thin-layer chromatographic method to determine process impurities in leucovorin calcium. J Pharm Sci. 1992 Dec;81(12):1204-9.

17.United States Pharmacopoeia, The USP Convention Inc., Rockville, 1980 20th ed.

18. Nicolas, E.C., Scholz, T.H, ‘Active drug substance impurity profiling part II. LC/MS/MS fingerprinting. J Pharm Biomed Anal. 1998 Jan;16(5):825-36

19. V. Madireddy, K.S. Babu, P. Narayanreddy Glob. J. Anal. Chem., 2 (2011), pp. 198–207

20.Verbeken, M., Suleman, S., Baert, B., Vangheluwe, E., Dorpe, S.V., Burvenich, C., Duchateau, L., Jansen, F.H., De Spiegeleer, B., 2011. Malaria J. 10, 51. http://dx.doi.org/10.1186/1475-2875-10-51.

21.Watson, D.G., Pharmaceutical Analysis. Churchill Livingstone, Edinburg, 1999 p 208.
How to Cite
Sony, M. S. A. (2019). A REVIEW ARTICLE ON INTRODUCTION OF ANALYTICAL INSTRUMENTS ANALYSIS IN PHARMACEUTICAL INDUSTRY ACCORDING TO PHARMACOPOEIA. Mintage Journal of Pharmaceutical and Medical Sciences (ISSN: 2320-3315), 1-4. Retrieved from http://mjpms.in/index.php/mjpms/article/view/493
Review Article(s)