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

Amaandika Galih Arintowibowo; Ririn Sumiyani; Kusuma Hendrajaya

doi:10.14710/jksa.22.4.150-156

DOI: https://doi.org/10.14710/jksa.22.4.150-156

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

Amaandika Galih Arintowibowo , Ririn Sumiyani, Kusuma Hendrajaya

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.

BibTex Citation Data :

@article{JKSA23083,
    author = {Amaandika Arintowibowo and Ririn Sumiyani and Kusuma Hendrajaya},
    title = {Validasi Metode Analisis Residu Mometasone furoate dan CIP100 Setelah Proses Pembersihan Peralatan Produksi di Industri Farmasi “XYZ”},
    journal = {Jurnal Kimia Sains dan Aplikasi},
  volume = {22},
    number = {4},
    year = {2019},
    keywords = {Mometasone furoate; Cleaning Validation; Surfaces of Production Equipment; analysis of Total Organic Carbon (TOC); HPLC},
    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},
   issn = {2597-9914},   pages = {150--156}  doi = {10.14710/jksa.22.4.150-156},
    url = {https://ejournal.undip.ac.id/index.php/ksa/article/view/23083}
}

Citation Format:

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

In Vol 22, No 4 (2019): Volume 22 Issue 4 Year 2019

Recent articles

Effect of Temperature, Pressure, and Reaction Time on Hydrogenation of Hexadecanoic Acid to 1-Hexadecanol Using a Ru-Sn(3.0)/C Catalyst Theoretical Study on the Use Cyano Acid Derivation as Electron Acceptors in Pelargonidin as Dye Compounds of Sensitized Solar Cells (DSSC) The Effect of Ratio LiBOB:TiO2 of Electrolyte Polymer Sheets as separators on the Electrochemical Performance of LTO-Based Lithium-Ion Batteries More recent articles

Most cited articles

Innovation of Carbon from Pectin Templated in Fabrication of Interlayer-free Silica-Pectin Membrane Preparasi Katalis Zeolit Alam Asam sebagai Katalis dalam Proses Pirolisis Katalitik Polietilena Pengaruh Variasi Jenis Asam terhadap Karakter Nanosilika yang Disintesis dari Abu Sekam Padi Isolasi Bakteri Termofilik Sumber Air Panas Gedongsongo dengan Media Pengaya Minimal YT (Yeast Tripton) serta Identifikasi Genotipik dan Fenotipik Activity Test of Suji Leaf Extract (Dracaena angustifolia Roxb.) on in vitro cholesterol lowering More cited articles

U. S. Food and Drug Administration. Validation of Cleaning Processes (7/93); Guide to Inspections Validation of Cleaning Processes. 2014 [cited 2019
World Health Organization, Supplementary Guidelines On Good Manufacturing Practices (GMP): Validation, in, World Health Organization, Geneva, Switzerland, 2005
Active Pharmaceutical Ingredient Committee (APIC), Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants, in, Active Pharmaceutical Ingredient Committee (APIC), 2016
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
United States Pharmacopeial (USP), USP 41 - NF 36 The United States Pharmacopeia and National Formulary 2018, Deutscher Apotheker Verlag, 2018
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
http://dx.doi.org/10.1590/S0100-40422007000400004
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
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
http://dx.doi.org/10.1590/S0100-40422010000100035
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
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
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
GE Analytical Instruments, SIEVERS M9 Total Organic Carbon Analyzer User Manual, in, GE Analytical Instruments, 2014
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: 2024-11-12 00:32:49

No citation recorded.

As an article writer, the author has the right to use their articles for various purposes, including use by institutions that employ authors or institutions that provide funding for research. Author rights are granted without special permission.

Author who publishes a paper at JKSA has the broad right to use their work for teaching and scientific purposes without the need to ask permission, including: used for (i) teaching in the author's class or institution, (ii) presentation at meetings or conferences and distributing copies to participants ; (iii) training conducted by the author or author's institution; (iv) distribution to colleagues for research use; (v) use in the compilation of subsequent authors' works; (vi) inclusion in a thesis or dissertation; (vi) reuse of part of the article in another work (with citation); (vii) preparation of derivative works (with citation); (viii) voluntary posting on open websites operated by authors or author institutions for scientific purposes (follow the CC BY-SA License).

Authors and readers can copy and redistribute material in any media or format, and mix, modify, and build material for any purpose but they must provide appropriate credit (provide article citation or content), providing links to the license, and indicate if there are changes.

The authors submitting a manuscript do so on the understanding that if accepted for publication, copyright of the article shall be assigned to Jurnal Kimia Sains dan Aplikasi (JKSA). Copyright encompasses rights to reproduce and deliver the article in all form and media, including reprints, photographs, microfilms and any other similar reproductions, as well as translations.

Reproduce any part of this journal, its storage in the database or its transmission by all forms or media is permitted does not need for written permission from JKSA. However, it should be cited as an honor in academic manners

JKSA and the Chemistry Department of Diponegoro University and the Editor make every effort to ensure that there are no data, opinions, or false or misleading statements published in JKSA. However, the content of the article is the sole and exclusive responsibility of each author.

The Copyright Transfer Form can be downloaded here: [Copyright Transfer Form - Indonesian] [Copyright Transfer Form - English]. The copyright form should be signed originally and send to the Editor in the form of printed letters, scanned documents sent via email or fax.

Adi Darmawan, Ph.D (Editor in Chief)

Editor in chief of Jurnal Kimia Sains dan Aplikasi (JKSA)

Chemistry Department, Faculty of Sciences and Mathematics, Diponegoro University

Jl. Prof. Soedarto, Kampus Undip Tembalang, Semarang, Central Java, Indonesia 50275
Email: jksa@live.undip.ac.id