skip to main content

Validasi Metode Analisis Residu Mometasone furoate dan CIP100 Setelah Proses Pembersihan Peralatan Produksi di Industri Farmasi “XYZ”

Validation of Mometasone furoate and CIP100 Residue Analysis Methods After Cleaning of Production Equipment in the “XYZ” Pharmaceutical Industry

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Surabaya, Indonesia

Received: 12 May 2019; Revised: 15 Jul 2019; Accepted: 15 Jul 2019; Published: 31 Jul 2019.
Open Access Copyright 2019 Jurnal Kimia Sains dan Aplikasi under http://creativecommons.org/licenses/by-sa/4.0.

Citation Format:
Cover Image
Abstract
In this study, the HPLC and Total Organic Carbon (TOC) analysis methods have been developed and validated for the determination of the amount of Mometasone furoate and CIP100 residues on the surface of production equipment and to confirm the efficiency of the cleaning procedure. Mometasone furoate and CIP100 have been chosen based on the worst case assessment approach. The limit of mometasone furoate contamination that has been determined is 100 ug/swab and the specified limit of CIP100 contamination is 100 ug/swab which should not be exceeded during sequential cleaning of the equipment. Mometasone furoate shows good linearity in the range 0.1-1.0 ppm for the HPLC method and CIP100 2.0-10.0 ppm for TOC Analysis. The percentage of recovery from stainless steel plates using swab sampling techniques was found in the limits of 95.12% and 99.93% respectively in the HPLC and TOC methods. Both methods are simple, inexpensive, short analysis time and high sensitivity for quantitative determination of Mometasone furoate and CIP100 on the surface of manufacturing equipment well below the contamination limit. The validated method meets the requirements for demonstration of the validation of residual cleaning of mometasone furoate and CIP100 on the surface of production equipment
Fulltext View|Download
Keywords: Mometasone furoate; Cleaning Validation; Surfaces of Production Equipment; analysis of Total Organic Carbon (TOC); HPLC

Article Metrics:

Article Info
Section: Research Articles
Language : ID
Statistics:
Share:
  1. U. S. Food and Drug Administration. Validation of Cleaning Processes (7/93); Guide to Inspections Validation of Cleaning Processes. 2014 [cited 2019
  2. World Health Organization, Supplementary Guidelines On Good Manufacturing Practices (GMP): Validation, in, World Health Organization, Geneva, Switzerland, 2005
  3. Active Pharmaceutical Ingredient Committee (APIC), Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants, in, Active Pharmaceutical Ingredient Committee (APIC), 2016
  4. Ramin Asgharian, Farzaneh Mehtarpour Hamedani, Asghar Heydari, Step by Step How to Do Cleaning Validation, International Journal of Pharmacy & Life Sciences, 5, 3, (2014) 3345-3366
  5. United States Pharmacopeial (USP), USP 41 - NF 36 The United States Pharmacopeia and National Formulary 2018, Deutscher Apotheker Verlag, 2018
  6. Edith Cristina Laignier Cazedey, Roberta de Cássia Pimentel Azevedo, Érika de Fátima Silva, Magali Benjamim de Araújo, Desenvolvimento e Validação De Metodologia Analítica Para Determinação De Itraconazol Em Produtos Farmacêuticos Por Clae, Quimica Nova, 30, 4, (2007) 774-776
  7. http://dx.doi.org/10.1590/S0100-40422007000400004
  8. Ana Cristina Isler, Gisely Cristiny Lopes, Mara Lane Carvalho Cardoso, João Carlos Palazzo de Mello, Development and Validation of A LC-Method for the Determination of Phenols in a Pharmaceutical Formulation Containing Extracts from Stryphnodendron adstringens, Quimica Nova, 33, 5, (2010) 1126-1129 http://dx.doi.org/10.1590/S0100-40422010000500023
  9. Márcia Camponogara Fontana, Felipe Kellermann Hurtado, Micheli Wrasse, Aline Augusti Boligon, Tarcieli Pozzebon Venturini, Clarice Madalena Bueno Rolim, Ruy Carlos Ruver Beck, Development and Validation of RP-LC and UV Spectrophotometric Methods to Assay Bromopride in Oral and Injectable Solutions, Quimica Nova, 33, 1, (2010) 208-211
  10. http://dx.doi.org/10.1590/S0100-40422010000100035
  11. Monika P. Tagliari, Gislaine Kuminek, Sílvia H. M. Borgmann, Charise D. Bertol, Simone G. Cardoso, Hellen K. Stulzer, Terbinafine: optimization of a LC method for quantitative analysis in pharmaceutical formulations and its application for a tablet dissolution test, Química Nova, 33, 8, (2010) 1790-1793 http://dx.doi.org/10.1590/S0100-40422010000800029
  12. Melton B. Affrime, Teddy Kosoglou, C. Mohan Thonoor, Brian E. Flannery, Jerry M. Herron, Mometasone Furoate Has Minimal Effects on the Hypothalamic-Pituitary-Adrenal Axis When Delivered at High Doses, CHEST, 118, 6, (2000) 1538-1546 http://doi.org/10.1378/chest.118.6.1538
  13. Srikumar Sahasranaman, Yufei Tang, Diana Biniasz, Guenther Hochhaus, A sensitive liquid chromatography–tandem mass spectrometry method for the quantification of mometasone furoate in human plasma, Journal of Chromatography B, 819, 1, (2005) 175-179 https://doi.org/10.1016/j.jchromb.2005.01.018
  14. GE Analytical Instruments, SIEVERS M9 Total Organic Carbon Analyzer User Manual, in, GE Analytical Instruments, 2014
  15. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology Q2(R1), in: ICH Harmonised Tripartite Guideline, 1994

Last update:

No citation recorded.

Last update:

No citation recorded.