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

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Keywords: Mometasone furoate; Cleaning Validation; Surfaces of Production Equipment; analysis of Total Organic Carbon (TOC); HPLC

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Section: Research Articles

Language : ID

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

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