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2013, Número 1

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Rev Cubana Farm 2013; 47 (1)


A validated RP-HPLC method for the determination of Irinotecan hydrochloride residues for cleaning validation in production area

Sunil RP, Sudhakar BK, Kumar N

Idioma: Ingles.
Referencias bibliográficas: 14
Paginas:
Archivo PDF: 351.73 Kb.


FRAGMENTO

Sin resumen


REFERENCIAS (EN ESTE ARTÍCULO)

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  2. Guide to inspections validation of cleaning processes, U.S. Food and Drug Administration, Office of Regulatory Affairs, Washington, DC, 1993, pp. 1-6.

  3. RxList. The Internet Drug Index. Camptosar Injection. [cited 2012 Jan 31]. Available from: http://www.rxlist.com/camptosar_inj-drug.htm

  4. Kawato Y, Aonuma M, Hirota Y, Kuga H, Sato K. Intracellular role of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11, Cancer Res., 1991; 51: 4187-4191.

  5. Kumar VK, Raju NA, Rani N, Rao JVLNS, Satyanarayana T. The estimation of irinotecan HCl in parenterals by RP-HPLC, Asian J. Research Chem. 2009; 2: 54-56.

  6. Balaram VM, Rao JV, Ramakrishna S, Ganesh GS, Krishna TB. Validated reverse phase HPLC method for the determination of Irinotecan in pharmaceutical dosage forms, E-J Chem., 2007; 4: 128-136.

  7. Mohammadi A, Esmaeili F, Dinarvand R, Atyabi F, Walker RB. Simultaneous determination of irinotecan hydrochloride and its related compounds by high performance liquid chromatography using ultraviolet detection, Asian J. Chem. 2010; 22: 3966-3972.

  8. Doods HM, Robert J, Rivory LP. The detection of photo degradation products of irrinotecn (CPT-11, Campto®, Camptosar®), in clinical studies, using high-performance liquid chromatography/atmospheric pressure chemical ionisation/mass spectroscopy, J. Pharm. Biomed. Anal. 1998; 17: 785-792.

  9. Khan S, Ahmed A, Guo W, Wang YF, Abu-Ware A, Ahmad I. A simple and sensitive LC/MS/MS assay for 7-ethyl-10-hydroxycamptothecin (SN-38) in mouse plasma and tissues: application to pharmacokinetic study of liposome entrapped SN-38 (LE0SN38), J. Pharm. Biomed. Anal. 2005; 37: 135-142.

  10. Forsyth RJ, Haynes DV, Cleaning validation in pharmaceutical research facility, Pharm. Technol. 1998; 22: 104-112.

  11. Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, Active Pharmaceutical Committee (APIC), 1-56.

  12. LeBlance DA, Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products, Pharm. Technol. 1998; 22 (10): 136-148.

  13. Fourman GL, Mullen MV, Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations, Pharm. Technol. 1993; 17 (4): 54-60.

  14. ICH Q2 (R1), Validation of Analytical Procedures: Text and Methodology, 2005.




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