Substances of pharmaceutical drug products go through thorough analyses to check the safety, efficacy as well as the quality of the final product. There are a number of shortcomings even though much has been done in the analytical methods used in recalls. Such challenges are those concerning method validation, sensitivity, specificity, reproducibility, and regulation. This article on major analytical problems in current pharmaceutical drug products outlines major limitations in the current pharmaceutical drug products while stressing the need to address these challenges for the populace’s benefit. We also deliberate on problems frequently encountered in chromatographic methods, spectroscopy, dissolution tests and microbiological methods. Also, the role of such enhanced analytical instruments as High-Resolution Mass Spectrometry (HRMS) and Nuclear Magnetic Resonance (NMR) spectroscopy in addressing analytical issues is described as well. Proposals for enhancing analytical processes, such as the utilization of superior procedures for the acquired data analysis and constant quality control, are provided. The current practices in pharmaceutical analytics are revisited, and the future prospects for research and development are discussed based on an extensive survey of the existing literature and case studies.

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1. Ahuja, S., & Scypinski, S. (2001). Modern pharmaceutical analysis: An overview. Handbook of Major Analytical Problems in Current Pharmaceutical Drug Products Jakkan et al.
2. Taylor, D., & Senac, T. (2014). Human pharmaceutical products in the environment–the “problem” in perspective. Chemosphere, 115, 95–99.
3. Singh, C., Rao, K., Yadav, N., Bansal, N., Vashist, Y., Kumari, S., & Chugh, P. (2023). A Review: Drug Excipient Incompatibility by FTIR Spectroscopy. Current Pharmaceutical Analysis, 19(5), 371–378.
4. The Drug Development Process, online: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
5. Görög, S. (2008). Drug safety, drug quality, drug analysis. Journal of Pharmaceutical and Biomedical Analysis, 48(2), 247–253.
6. Jain, S., & Shah, R. P. (2023). Drug-excipient compatibility study through a novel vial-in-vial experimental setup: a benchmark study. AAPS PharmSciTech, 24(5), 117.
7. Waterbeemd, H. V., & Testa, B. (2009). Drug bioavailability: Estimation of solubility, permeability, absorption, and bioavailability. Wiley-VCH.
8. Yalkowsky, S. H., & Banerjee, S. (1992). Solubility and partitioning. Handbook of Environmental Chemistry, 2H, 31–48.
9. Sugano, K. (2009). Introduction to solubility and dissolution phenomena. Solubility in Pharmaceutical Chemistry, 1–25.
10. Müller, R. H., Keck, C. M., & Krystewskyj, B. (2022). Nanostructured lipid carriers for poorly soluble drugs: Focus on drug solubility enhancement. Advanced Drug Delivery Reviews, 180, 114–128.
11. Beveridge, R., Calabrese, R., & Holliday, S. (2013). Pharmaceutical analysis: Modern methods and strategies. Analytical Chemistry, 85(7), 1101–1107.
12. Bansal, A., & Kaushik, R. (2020). An overview of drug-polymer interactions: Implications on drug stability. International Journal of Drug Development and Research, 12(1), 55–63.
13. Hamedi, H., & Ghourchian, H. (2023). Green pharmaceutical analysis methods: Enhancing sustainability. Trends in Analytical Chemistry, 161, 116984.
14. Paul, R., & Wagner, R. (2021). Advances in pharmaceutical FTIR spectroscopy. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 251, 119562.
15. Goodman, S., & Harwood, M. (2018). Validation of chromatographic methods in pharmaceutical analysis. Journal of Chromatography A, 1579, 155–171.
16. Kulkarni, A., & Gawande, M. (2015). High-throughput screening in drug discovery: Impact and future directions. Biochemical Pharmacology, 98(2), 99–113.

Substances of pharmaceutical drug products go through thorough analyses to check the safety, efficacy as well as the quality of the final product. There are a number of shortcomings even though much has been done in the analytical methods used in recalls. Such challenges are those concerning method validation, sensitivity, specificity, reproducibility, and regulation. This article on major analytical problems in current pharmaceutical drug products outlines major limitations in the current pharmaceutical drug products while stressing the need to address these challenges for the populace’s benefit. We also deliberate on problems frequently encountered in chromatographic methods, spectroscopy, dissolution tests and microbiological methods. Also, the role of such enhanced analytical instruments as High-Resolution Mass Spectrometry (HRMS) and Nuclear Magnetic Resonance (NMR) spectroscopy in addressing analytical issues is described as well. Proposals for enhancing analytical processes, such as the utilization of superior procedures for the acquired data analysis and constant quality control, are provided. The current practices in pharmaceutical analytics are revisited, and the future prospects for research and development are discussed based on an extensive survey of the existing literature and case studies.

🔒 This is a subscription article

Full text is available to subscribers and institutional members. Please choose an option below to access it.

1. Ahuja, S., & Scypinski, S. (2001). Modern pharmaceutical analysis: An overview. Handbook of Major Analytical Problems in Current Pharmaceutical Drug Products Jakkan et al.
2. Taylor, D., & Senac, T. (2014). Human pharmaceutical products in the environment–the “problem” in perspective. Chemosphere, 115, 95–99.
3. Singh, C., Rao, K., Yadav, N., Bansal, N., Vashist, Y., Kumari, S., & Chugh, P. (2023). A Review: Drug Excipient Incompatibility by FTIR Spectroscopy. Current Pharmaceutical Analysis, 19(5), 371–378.
4. The Drug Development Process, online: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
5. Görög, S. (2008). Drug safety, drug quality, drug analysis. Journal of Pharmaceutical and Biomedical Analysis, 48(2), 247–253.
6. Jain, S., & Shah, R. P. (2023). Drug-excipient compatibility study through a novel vial-in-vial experimental setup: a benchmark study. AAPS PharmSciTech, 24(5), 117.
7. Waterbeemd, H. V., & Testa, B. (2009). Drug bioavailability: Estimation of solubility, permeability, absorption, and bioavailability. Wiley-VCH.
8. Yalkowsky, S. H., & Banerjee, S. (1992). Solubility and partitioning. Handbook of Environmental Chemistry, 2H, 31–48.
9. Sugano, K. (2009). Introduction to solubility and dissolution phenomena. Solubility in Pharmaceutical Chemistry, 1–25.
10. Müller, R. H., Keck, C. M., & Krystewskyj, B. (2022). Nanostructured lipid carriers for poorly soluble drugs: Focus on drug solubility enhancement. Advanced Drug Delivery Reviews, 180, 114–128.
11. Beveridge, R., Calabrese, R., & Holliday, S. (2013). Pharmaceutical analysis: Modern methods and strategies. Analytical Chemistry, 85(7), 1101–1107.
12. Bansal, A., & Kaushik, R. (2020). An overview of drug-polymer interactions: Implications on drug stability. International Journal of Drug Development and Research, 12(1), 55–63.
13. Hamedi, H., & Ghourchian, H. (2023). Green pharmaceutical analysis methods: Enhancing sustainability. Trends in Analytical Chemistry, 161, 116984.
14. Paul, R., & Wagner, R. (2021). Advances in pharmaceutical FTIR spectroscopy. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 251, 119562.
15. Goodman, S., & Harwood, M. (2018). Validation of chromatographic methods in pharmaceutical analysis. Journal of Chromatography A, 1579, 155–171.
16. Kulkarni, A., & Gawande, M. (2015). High-throughput screening in drug discovery: Impact and future directions. Biochemical Pharmacology, 98(2), 99–113.