VALIDASI METODE ANALISIS ANDROGRAFOLID DALAM MATRIKS SEDIAAN TABLET MENGGUNAKAN KROMATOGRAFI CAIR KINERJA TINGGI (KCKT)

AKHMAD GINANJAR, - (2023) VALIDASI METODE ANALISIS ANDROGRAFOLID DALAM MATRIKS SEDIAAN TABLET MENGGUNAKAN KROMATOGRAFI CAIR KINERJA TINGGI (KCKT). Skripsi thesis, Sekolah Tinggi Farmasi Indonesia.

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Abstract

Validasi metode analisis merupakan elemen penting dari kontrol kualitas, karena validasi memberikan jaminan bawah hasil pengukuran analisisnya akurat, spesifik, dapat reprodusibel, dan toleran terhadap kisaran analit yang akan dianalisis. Penetlitian ini bertujuan untuk menetapkan validasi metode analisis kadar andrografolid dalam sediaan tablet menggunakan metode kromatografi cair kinerja tinggi (KCKT) dengan menggunakan kolom C-18 (4,6 mm × 150 mm; 5 µm), fase gerak metanol : air (65:35), dengan kecepatan alir 1,0 mL/menit dan pada panjang gelombang 224 nm. Parameter validasi metode analisis yang ditentukan pada penelititan ini yaitu linieritas dan rentang, batas deteksi, batas kuantiasis, akurasi, dan presisi. Hasil penelitian menunjukan koefisien kolerasi yaitu 0,9999, rentang konsentrasi 10 ppm – 100 ppm, batas deteksi 2,52 ppm, batas kuantitasi 7,63 ppm, akurasi 100,60%, dan presisi 100,72%. Berdasarkan hasil penelitian, semua parameter validasi memenuhi persyaratan yang ditetapkan sehingga metode KCKT hasil penelitian ini dapat diaplikasikan untuk penetapan kadar andrografolid dalam sediaan tablet. --- Method validation is an essential element of quality control, as it ensures that the results of the analytical measurements are accurate, specific, reproducible, and tolerant to the range of analytes to be analyzed. This research aimed to establish the validation of the analysis method for the determination of andrographolide content in tablet formulations using High-Performance Liquid Chromatography (HPLC) with a C-18 column (4.6 mm × 150 mm; 5 µm), mobile phase of methanol:water (65:35), flow rate of 1.0 mL/min, and detection wavelength of 224 nm. The method validation parameters determined in this study include linearity and range, detection limit, quantitation limit, accuracy, and precision. The research results showed a correlation coefficient of 0.9999, concentration range of 10 ppm to 100 ppm, detection limit of 2.52 ppm, quantitation limit of 7.63 ppm, accuracy of 100.60%, and precision of 100.72%. Based on the research findings, all validation parameters met the specified requirements, indicating that the HPLC method established in this study can be applied for the determination of andrographolide content in tablet formulations.

Item Type: Thesis (Skripsi)
Uncontrolled Keywords: Andrografolid, validasi metode analisis, KCKT andrographolide, validation of analysis methods, HPLC
Subjects: Q Science > QD Chemistry
R Medicine > RM Therapeutics. Pharmacology
Divisions: Program Studi S1 Farmasi
Depositing User: pustakawan - -
Date Deposited: 21 Jun 2024 09:01
Last Modified: 21 Jun 2024 09:01
URI: http://repository.stfi.ac.id/id/eprint/284

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