PENGEMBANGAN DAN VALIDASI METODE KCKT-ELSD UNTUK PENETAPAN KADAR DAN UJI INDIKASI STABILITAS SUKRALFAT
Sucralfate or aluminum sucrose octasulfate commonly used as a cytoprotective agent for peptic ulcer. To ensure quality, efficacy and safety of sucralfate for treatment, it is necessary to develop and validate method for the analysis of sucralfate. The objective of this study was to develop and val...
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| Format: | Theses and Dissertations NonPeerReviewed |
| Language: | Indonesian Indonesian |
| Published: |
2018
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| Subjects: | |
| Online Access: | http://repository.unair.ac.id/75029/1/TF.%2030-18%20Dwi%20p%20Abstrak.pdf http://repository.unair.ac.id/75029/2/TF.%2030-18%20Dwi%20p.pdf http://repository.unair.ac.id/75029/ http://lib.unair.ac.id |
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| Institution: | Universitas Airlangga |
| Language: | Indonesian Indonesian |
| Summary: | Sucralfate or aluminum sucrose octasulfate commonly used as a cytoprotective agent for peptic ulcer. To ensure quality, efficacy and safety of
sucralfate for treatment, it is necessary to develop and validate method for the
analysis of sucralfate. The objective of this study was to develop and validate a
HPLC-ELSD method for analysis of sucralfate in raw material and suspension
dosage form. The chromatographic condition was achieved using Phenomenex
Luna ODS3 column (250 x 4.6 mm i.d.) with 5μm particle size, mobile phase was
prepared by mixing acetonitrile : TFA 0.1 % (50:50) in isocratic elution at the
flow rate of 0.8 ml/min. The column temperature was 25oC and the injection
volume was 10 μl. The temperature of nebulization and evaporation of the ELSD
was set at 70oC and 30oC, respectively and gas flow rate at 1.8 SLM. This method
was found to be selective and accurate with % recovery between 92% and 102 %.
The precision was expressed as % RSD and the result was ≤ 2 %. The retention
time of sucralfate is 2.29 min with a run time of 4 min. The linearity of the
proposed method was investigated in the range of 300 – 800 μg/ml with
coefficient correlation (r) and Vxo was 0.999 and 0.765, respectively. All the
validation parameters like selectivity, linearity, range, accuracy and precision met
the acceptance criteria according to ICH guidelines. Overall, the proposed method
is rapid, simple and selective for detection and determination of sucralfate. |
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