Determination of scums in medicine materials
Keywords:
determination, scums, medicine materialsAbstract
The current study is describing the main degrading scums in bromazepam, diazepam, Cefixime trihydrate, cefazolin sodium, simvastatin, and lovastatin, among other materials and manufactured items. HPLC was used to characterize pharmaceutical substance scums by comparing their retention lengths to reference standards. Before deciding, they sorted all the material from its main scums. Scums fell between 1.23 to 20.57 min, and parent compounds had try values between 2.71 and 9.22. Thus, isolating and identifying these compounds takes 20 minutes. This study identified parent compounds and degradation products using HPLC after confirming the European Pharmacopeial methodology. HPLC method validation for parent pharmaceuticals and degradation scums examined specificity, linearity, precision, and accuracy. The process can be applied to commodities and waste products using each compound's values for these qualities. 98%–102% of parent and scum materials are recovered. The experimental technique repeats within 3%. In compliance with pharmacopeial and regulatory norms, scums above 0.1% must be determined for pharmaceutical safety, efficacy, and quality. It's vital due to the effects of packaging, transit, storage, and manufacturer synthetic pathways. Adjuvants may cause degradation scums. The selected drugs' raw material and finished product levels of their main degrading scums were examined, and a concentration range was provided.
Downloads
References
Ahuja, S. (2003). Isolation and characterization of impurities. in: Ahuja, S., Alsante, K.M. Eds., Handbook of Isolation and characterization of impurities in pharmaceuticals, Academic press, Elsevier, USA, p. 2.
Mollica, J. A., Ahuja, S., Cohen, J. (1978). J. Pharm. Sci., 67, 443.
Argentine, M.D., Owens, P.K., Olsen, B.A.(2007). Adv. Drug Deliv. Rev. 59, 12- 28.
ICH Harmonized Tripartite Guidelines for Stability Testing of New Drug Substances and Products, September, 1994 (ICH Q1A).
ICH Harmonized Tripartite Guidelines for Impurities in Drug Substances, October 2006, Q3A (R2).
NDAs: Impurities in drug substances, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), February 2000. 185
ANDAs: FDA Impurities in drug substances, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), June 2009.
United States Pharmacopeia 32 (2009). United States Pharmacopeial Convention, Rockville, MD, pp. 1666-1667, 1671-1672, 1710-1712, 1933-1934, 2555-2556, 3234-3235.
Waterman, K. C., Adami, R.C., Hong, J. (2003). Impurities in drugs products, In: Ahuja, S., Alsante, K.M. Eds., Handbook of Isolation and characterization of impurities in pharmaceuticals, Academic press, Elsevier, USA, p. 75-76.
Rawlins, E.A., Ed. (1977). Drug Stability, Bentley’s Textbook of Pharmaceutics, 8th ed., Bailliere Tindall, London, Chap. 10.
Lloyd, D., Mcnab, H. (1998). Adv. heter. Chem. 71, 1-56.
Malenovic, A., Stojanovic, B. J., Ivanovic, D., Medenica, M. (2010). J. Liq. Chrom. Related Technol. 33, 536–547.
Kaufman, M.J. (1990). Pharm. Res. 7, 289–292.
Smith, G.B., DiMichelle, L., Colwell, L., Dezeny, G., Douglas, A., Reamer, R., Verhoeven, T. (1993). Tetrahedron 49, 4447–4462.
Vree, T.B., Dammers, E., Ulc, L., Horkovics-Kovats, S., Raska, M., Merkx, I. (2003). Sci. World J. 11, 1332-1343. 35. Scott, S.J., Gluckman, M.I. (1964). J. Pharm. Sci. 53, 577– 590.
Skolnick, P.S., Paul, M. (1981). Ann. Rep. Med. Chem. 16, 21–29.
Tiller, J.W.G., Schweitzer, I. (1992). Drugs 44, 165–169.
Prut, L., Belzung, C. (2003). Eur. J. Pharmacol. 463, 3–33.
Sanchez, C., (2003). Eur. J. Pharmacol. 463. 33–143.
Katzung, B.G. (1995). Basic and Clinical Pharmacology, 6th ed., Appleton and Lange, East Norwalk, pp. 227-231. 187
Hassan, M.A., Abounassif, M.A. (1987). Anal. Prof. Drug Subst. 16, 1–50.
Sweetman, S.C., Ed. (2007). Martindale The Complete Drug Reference, 35th ed., Pharmaceutical press, London., pp. 197-198, 200-201, 862, 884-890, 1193-1194, 1250 -1254.
Bernard, P., Parker, K.L. (2001). in: Hardman, J.G., Limpard, L.E., Eds., Goodman & Gilman’s Pharmacological Basis of Therapeutics, 10th ed., Mc Graw Hill Medical Publishing Division, New York., pp. 245-252, 875-882, 1064-1071.
Connor, P.O., Feely, J., Shepard, J. (1990). Br. Med. J. 300, 667–672.
Vickers, S., Duncan, C.A., Chen, J.W., Rosegay, A., Duggan, D.E. (1990). Drug Metab. Dispos. 18, 138–145.
Fujioka, T., Nara, F., Tsujika, Y., Fukushige, J., Fukami, M., Kuroda, M. (1995). Biochim. Biopshys. Acta, 1254, 7–12.
Arai, M., Serizawa, N., Terahara, A., Tsujita, Y., Tanaka, M., Masuda, H., Ishikawa, S. (1988). Sankyo Kenkyusho Nempo 40, 1–38.
Ellison, D.K., Moore, W.D., Petts, C.R. (1993). Anal. Prof. Drug Subst. Excipients 22, 359– 388.
Baertschi, S.W., Ed. (2005). Pharmaceutical Stress Testing, Predicting Drug Disposition. Taylor & Francis, London.
British Pharmacopeia (2009). Her Majesty’s Stationary office, London, pp. 278- 279, 392-394, 397-398, 637-638, 1243-1244, 1831-1832.
Moffat, A.C., Osselton, M.D., Widdop, B. (2004). Clarke’s Analysis of Drugs and Poisons, 3rd ed., Pharmaceutical Press, London, p. 694.
Published
How to Cite
Issue
Section
Copyright (c) 2023 International journal of health sciences
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the International Journal of Health Sciences (IJHS) are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJHS right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.
Articles published in IJHS can be copied, communicated and shared in their published form for non-commercial purposes provided full attribution is given to the author and the journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
This copyright notice applies to articles published in IJHS volumes 4 onwards. Please read about the copyright notices for previous volumes under Journal History.
