QUALITY EVALUATION OF INJECTABLE KETOROLAC TROMETHAMINE PREPARATIONS BASED ON PHARMACOPEIAL STANDARDS
Abstract
Injectable formulations of ketorolac tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID), are widely used for the management of moderate to severe acute pain. Due to the parenteral route of administration, these preparations must comply with strict pharmacopeial quality requirements to ensure safety, efficacy, and consistency. This article provides a comprehensive review of quality assessment approaches for ketorolac tromethamine injections based on internationally recognized pharmacopeial standards, including the United States Pharmacopeia (USP), the British Pharmacopoeia (BP), and the State Pharmacopoeia (GF XI). Special attention is given to physicochemical parameters, chromatographic purity, microbiological safety, and quantitative determination methods.
Keywords
x
References
- Xolmatov, J. O. "QUANTITATIVE DETERMINATION METHODS FOR LEVOCARNITINE IN PHARMACEUTICAL SOLUTIONS." Экономика и социум 5-1 (132) (2025): 863-865.
- Xolmatov, J. O. (2025). ANALYTICAL METHOD DEVELOPMENT FOR PHARMACEUTICAL SOLUTIONS. Экономика и социум, (5-1 (132)), 866-869.
- United States Pharmacopeial Convention (2023) United States Pharmacopeia and National Formulary (USP–NF). Rockville, MD: USP.
- Mamatisakova, G. A., Umirzaqova, N. S., Ziyayeva, M. K., Mirzaalimov, S. T., Xo'jamberdiyeva, Y. G., Xolmatov, J. O., ... & Xusanbayeva, Z. R. (2024). FROM PHARMACEUTICAL PROPERTIES OF BISMUTH DRUGS TO CLINICAL EFFICACY. Bulletin of Pure & Applied Sciences-Zoology, 43.
- Voxobjon o‘g‘li, Pazliddinov Abdulvohid. "High-Performance Liquid Chromatography (HPLC) in the Analysis of Injectable Pharmaceutical Forms: Applications and Advantages." Journal of Modern Educational Achievements 5.5 (2025): 18-22.
- Pazliddinov, A. V. "ADDICTION IS THE PLAGUE OF THE CENTURY." Экономика и социум 12-2 (103) (2022): 120-122.
- Pazliddinov, A. V. "ADDICTION IS THE PLAGUE OF THE CENTURY." Экономика и социум 12-2 (103) (2022): 120-122.
- British Pharmacopoeia Commission (2013) British Pharmacopoeia. London: The Stationery Office.
- State Pharmacopoeia of the Russian Federation (2018) State Pharmacopoeia of the Russian Federation, 14th edn. Moscow: Ministry of Health of the Russian Federation.
- Snyder, L.R., Kirkland, J.J. and Dolan, J.W. (2010) Introduction to Modern Liquid Chromatography. 3rd edn. Hoboken, NJ: Wiley.
- Kazakevich, Y. and Lobrutto, R. (2007) HPLC for Pharmaceutical Scientists. Hoboken, NJ: Wiley-Interscience.
- Blessy, M., Patel, R.D., Prajapati, P.N. and Agrawal, Y.K. (2014) ‘Development of forced degradation and stability indicating studies of drugs—A review’, Journal of Pharmaceutical Analysis, 4(3), pp. 159–165. https://doi.org/10.1016/j.jpha.2013.09.003