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

• Main Author: Badrus Sholeh, Aries
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44522
• Institution: Institut Teknologi Bandung

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.