COMPARISON OF ASSAY METHOD AND ANALYSIS OF THEIR IMPACTS TO THE QUALITY CONTROL EFFICIENCY OF A FIXED DOSE COMBINATION TABLET OF RIFAMPICIN AND ISONIAZID IN PT PHAPROS TBK
The purpose of this research is to compare spectrophotometry method against HPLC method to determine the concentration of a fixed dose combination of rifampisin 150 mg isoniazid 150 mg, and to analyze its efficiency impacts. The selected wavelength was 479 nm for rifampicin and 295,3 nm in first...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/44522 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | The purpose of this research is to compare spectrophotometry method against
HPLC method to determine the concentration of a fixed dose combination of
rifampisin 150 mg isoniazid 150 mg, and to analyze its efficiency impacts. The
selected wavelength was 479 nm for rifampicin and 295,3 nm in first derivative
for isoniazid and both using methanol as solvent. Calibration curve of both
rifampicin and isoniazid were found linear within a range of 12 –36 µg/ml. The
accuracy of the method is determined by recovery study and found within 98,0 to
102,0% for both active ingredients. The % RSD values for precision and
intermediate precision were found less than 2,0%. The method of HPLC was
existing method and has been validated in quality control laboratory of PT
Phapros Tbk. The upper limit of confidence interval in the precision comparison
of both method was found less than 4,0. The average of recovery value in the
accuracy comparison was found no significance difference for both methods using
Student t-test. The using of spectrophotometry method was successfully proven to
be efficient compare to HPLC method in the material usage, time of testing,
electrical energy and man power.
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