ANDREY SEPTIAN PERMANA, - (2024) VALIDASI METODE ANALISIS ANDROGRAFOLID DALAM SEDIAAN TABLET MENGGUNAKAN KROMATOGRAFI CAIR KINERJA TINGGI (KCKT). Skripsi thesis, Sekolah Tinggi Farmasi Indonesia.
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Abstract
Validasi metode analisis merupakan komponen paling penting dalam kontrol kualitas sediaan obat. Sampai saat ini belum terdapat tablet andrografolid, namun untuk sediaan tablet sambiloto sudah banyak ditemukan dipasaran, sehingga perlu dilakukan pengembangan metode analisis untuk penetapan kadar andrografolid dalam sediaan tablet. Penelitian ini bertujuan untuk memvalidasi metode analisis andrografolid menggunakan KCKT pada sediaan tablet, kemudian metode tervalidasi diaplikasikan untuk mengetahui kadar andrografolid dalam tablet sambiloto yang beredar di pasaran. Penelitian ini dilakukan melalui beberapa tahapan yaitu pembuatan sediaan tablet andrografolid, evaluasi tablet, validasi metode analisis dan penetapan kadar andrografolid dalam sediaan tablet yang beredar di pasaran. Sistem KCKT yang digunakan C-18 (4,6 mm × 150 mm; 5 µm), fase gerak metanol : air (65:35), kecepatan alir 1,0 mL/menit, dan panjang gelombang 224 nm. Hasil penelitian yang dilakukan menunjukkan, bahwa evaluasi sediaan tablet diperoleh kadar air granul 3,17%, distribusi ukuran partikel 56,71%, sudut istirahat 9,65o, kecepatan alir 25 g/detik, kompresibilitas 14,29%, rasio hausner 1,14, keseragaman ukuran diameter 6,12 mm, tebal 4,54 mm, keseragaman bobot 151,74 mg, waktu hancur maksimal 1,31 menit, kekerasan tablet 6,08 kg/cm2, friabilitas 0,13% dan friksibilitas 0,14%. Hasil validasi metode analisis menunjukkan nilai linearitas dengan koefisien kolerasi yaitu 0,9999, batas deteksi 2,19 ppm, batas kuantitasi 6,63 ppm, akurasi yang direpresentasikan dengan nilai rata-rata % perolehan kembali yaitu 100,23 % dan presisi dengan nilai RSD 0,26%. Semua parameter validasi memenuhi persyaratan sehingga metode ini dapat digunakan untuk analisis andrografolid dalam sediaan tablet. Hasil penetapan kadar andrografolid dalam 3 sediaan tablet andrografolid 98,35% ± 0,005%, sedangkan pada sampel tablet CXP 0.70% ± 0% dan pada tablet SBLT didapatkan kadar dengan nilai rata-rata nya sebesar 3.46% ± 0%. ---- Validation of analytical methods is a crucial component in the quality control of pharmaceutical preparations. Currently, there are no existing andrografolide tablets, but there are many sambiloto tablet preparations available in the market. Therefore, it is necessary to develop an analytical method for determining the content of andrografolide in tablet preparations. This study aims to validate an analytical method for andrografolide using HPLC in tablet preparations, and then apply the validated method to determine the content of andrografolide in sambiloto tablets available in the market. The research involves several stages: preparation of andrografolide tablets, tablet evaluation, method validation, and determination of andrografolide content in commercially available tablet preparations. The HPLC system used includes a C-18 column (4.6 mm × 150 mm; 5 µm), a mobile phase of methanol (65:35), a flow rate of 1.0 mL/min, and a wavelength of 224 nm. The research results showed that the tablet evaluation yielded a moisture content of 3.17% in the granules, a particle size distribution of 56.71%, an angle of repose of 9.65°, a flow rate of 25 g/sec, compressibility of 14.29%, a Hausner ratio of 1.14, uniform diameter size of 6.12 mm, thickness of 4.54 mm, weight uniformity of 151.74 mg, a maximum disintegration time of 1.31 minutes, tablet hardness of 6.08 kg/cm², tablet friability of 0.13% and friksibility 0,14%. The validation results of the analytical method showed a linearity value with a correlation coefficient of 0.9999, a detection limit of 2.19 ppm, a quantitation limit of 6.63 ppm, accuracy represented by an average recovery percentage of 100.23%, and precision with an RSD value of 0.26%. All validation parameters meet the requirements, indicating that this method can be used for the analysis of andrografolide in tablet preparations. The determination of andrografolide content in three andrografolide tablet preparations resulted in an average content of 98.35% ± 0.005%, while in CXP tablet samples, the content was 0.70% ± 0%, and in SBLT tablets, the average content was 3.46% ± 0%.
| Item Type: | Thesis (Skripsi) |
|---|---|
| Uncontrolled Keywords: | andrografolid, KCKT , validasi metode analisis. ---- andrographolide, HPLC, validation of analytical methods |
| Subjects: | Q Science > QD Chemistry R Medicine > RM Therapeutics. Pharmacology |
| Divisions: | Program Studi S1 Farmasi |
| Depositing User: | pustakawan - - |
| Date Deposited: | 26 Aug 2024 02:55 |
| Last Modified: | 26 Aug 2024 02:55 |
| URI: | http://repository.stfi.ac.id/id/eprint/1046 |
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