VALIDASI DAN PENETAPAN KADAR KETOKONAZOL TABLET DOSIS 200 MG MEREK DAGANG DAN GENERIK SECARA SPEKTROFOTOMETRI UV TAHUN 2018

Nazri, Muhammad (2018) VALIDASI DAN PENETAPAN KADAR KETOKONAZOL TABLET DOSIS 200 MG MEREK DAGANG DAN GENERIK SECARA SPEKTROFOTOMETRI UV TAHUN 2018. Undergraduate thesis, Institut Kesehatan Helvetia.

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Abstract

Ketoconazole is one of the most commonly used azole antifungal agents in the community and is cheaper compared to other azole groups. Quality Test is laboratory testing conducted to prove the quality of the drug is always consistent with the standards and requirements. One of the quality test requirements is the determination of the level of the drug so that the drug can achieve the desired therapeutic effect. This study aims to validate the method and the determination of Ketoconazole levels tablet with a dose of 200 mg on the market by UV spectrophotometry.
This research method used a quantitative research method by UV spectrophotometry with linearity parameters, accuracy, precision, detection limit and limit of quantitation. The validation method aims for the determination Farmyco (SANBE), Muzoral (PT. MOLEX AYUS), Ketoconazol (OGB dexa), Omegzole (PT. MULTIFA), Mycoral (KALBE) levels.
The results of the validation of Ketoconazole with methanol solvent showed a correlation coefficient of 0.9988, % recovery with an accuracy of 80 % with a range of 93.8 % - 100 %, at 100 % accuracy of 95 %, at 120 % accuracy of 89.6 % - 93.8 % Precision % RSD is 0.492 %. Detection limit of 2.9 ppm, quantitation limit of 9.7 ppm. Based on the data obtained, the average level of the sample is Mycoral 91.1 % ± 2.0 %, Ketoconazol 95.2 % ± 3.6 %, Omegzole, 92.0 % ± 1.5 %, Farmyco 92.3 % ± 0.4 %, Muzoral 99.5 % ± 1.7 %.
In this study the method validation fulfilled the requirements of the validation test parameters, namely the correlation coefficient value above 0.98 %, Recovery was between 80 % - 110 %, precision was % RSD ≤ 6 % all Ketoconazole samples fulfilled Indonesian Pharmacopoeia Edition IV requirements which were at 90 % - 110 %.

Item Type:	Doktoral (Undergraduate)
Additional Information:	Keywords: 200 mg Ketoconazole Tablet, UV Spectrovotometry, Method Validation and Level Determination
Subjects:	Fakultas Farmasi dan Kesehatan > Farmasi Fakultas Farmasi dan Kesehatan > Farmasi > Ilmu Resep
Divisions:	Fakultas Farmasi dan Kesehatan > S1 Farmasi
Depositing User:	Muhammad - Nazri
Date Deposited:	27 Feb 2020 05:46
Last Modified:	27 Feb 2020 08:19
URI:	http://repository.helvetia.ac.id/id/eprint/1678

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