eprintid: 13555 rev_number: 8 eprint_status: archive userid: 2319 dir: disk0/00/01/35/55 datestamp: 2022-10-09 07:02:09 lastmod: 2022-10-09 07:02:09 status_changed: 2022-10-09 07:02:09 type: thesis metadata_visibility: show creators_name: Kusumaningtyas Nova, Aulia creators_name: Supandi Supandi, Supandi creators_name: Almawati Situmorang, Almawati creators_id: supandi@uhamka.ac.id creators_orcid: 0000-0002-9233-1557 creators_orcid: 0000-0002-9233-1557 title: Optimasi Dan Validasi Metode Analisis Atorvastatin Dalam Plasma In Vitro Secara Kromatografi Cair Kinerja Ultra Tinggi-Tandem Spektrometer Massa (Kckut-Sm) ispublished: pub subjects: RS divisions: 48201 abstract: Atorvastatin termasuk ke dalam golongan obat anti hiperlipidemia yang masuk ke dalam kategori obat wajib bioekivalensi (BE). Penelitian ini bertujuan untuk memperoleh kondisi optimum untuk analisis atorvastatin dalam plasma in vitro menggunakan kromatografi cair kinerja ultra tinggi-tandem spektrometer massa (KCKUT-SM) dengan detektor Waters Triple Quadropole (TQ) dan melakukan validasi metode analisis tersebut. Analisis secara kromatografi dilaksanakan dengan teknik gradient pada kolom fase terbalik kolom BEH C18, fase gerak asetonitril-asam asetat (variasi 2), dengan laju alir variasi 2, dan dideteksi pada m/z 559,25>440,38 untuk analit utama dan m/z 260,06> 183,166 untuk baku dalam. Teknik penyiapan sampel dilakukan dengan cara ekstraksi cair-cair menggunakan etil asetat. Propranolol digunakan sebagai baku dalam. Metode ini valid menurut EMEA dalam Guideline on bioanalytical method validation (2011), dengan persamaan regresi linear y = 0.017x + 0.0048 dan nilai koefisien korelasi r = 0,9988, kurva linier pada kisaran konsentrasi 1-50 ng/mL, batas terendah kuantitasi (LLOQ) adalah sebesar 1,0 ng/mL. Hasil uji akurasi atorvastatin intra hari diperoleh %diff dan antar hari telah memenuhi persyaratan. Validasi pada penelitian ini dilakukan secara parsial. Kata kunci: validasi parsial, KCKUT-SM, atorvastatin, plasma in vitro. date: 2022-03-07 date_type: completed full_text_status: restricted institution: Univerisitas Muhammadiyah Dr Hamka department: Fakultas Farmasi Dan Sains thesis_type: bachelor thesis_name: bphil referencetext: A. Zarghi, A. Shafaati, SM. Foroutan, A. Khoddam. 2005. A Simple and Rapid HPLC Method for The Determination of Atorvastatin in Human Plasma with UV Detection and its Application to Pharmacokinetic Studies. Department of Pharmaceutical Chemistry, School of Pharmacy, Shaheed Beheshti University of Medical Sciences. Tehran, Iran. Hlm. 451. Abdallah Ola M. 2011. RP-HPLC Determination of Three Anti-Hyperlipidemic Drugs in Spiked Human Plasma and in Dosage Forms. E-Journal of Chemistry. Hlm. 753-761. Al-Akkam Entidhar J., Rasool A. A. 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Bachelor thesis, Univerisitas Muhammadiyah Dr Hamka. document_url: http://repository.uhamka.ac.id/id/eprint/13555/1/FFS_FARMASI_S03-170320_AULIA%20NOVA%20KUSUMANINGTYAS.pdf