High Performance Liquid Chromatography Validation of Isoniazid Analysis Method in 2 Fixed-Dose Combination Dispersible Tablet
DOI:
https://doi.org/10.23917/pharmacon.v23i1.6912Keywords:
FDC, HPLC, Isoniazid, TBC, Validation of Analytical MethodAbstract
Tuberculosis (TB) is a severe disease that causes significant morbidity and mortality worldwide, including in children. Combination therapy of isoniazid and rifampicin (two-fixed drug combination (2 FDC)) is recommended for children in the advanced stage, based on body weight. The dissolving test requirements for producing two FDC dispersible tablets, however, are not listed in the Indonesian Pharmacopoeia or other standard book. Because the only method of analysis presently in use is the ratio of the outcomes of the rifampicin and isoniazid dissolutions in the capsules, new methods of analysis must be developed and validated for dispersible tablets. This research aims to develop analytical methods for determining isoniazid levels in 2 FDC dispersible tablet formulations. The method uses High Performance Liquid Chromatography (HPLC) with a C18 column (4.6 mm x 250 mm, 5 µm) and UV-Vis detectors at 254 nm. The mobile phase is Water:Phosphate Buffer:Methanol (850:50:10), which is delivered at a flow rate of 1.5 ml/min. The validation parameter test results in correlation coefficients (r) 0.9995, LOD 0,00038724 mg/mL, LOQ 0.00117346 mg/mL, % recovery 99.51% in the accuracy test, and %RSD 0.41% in the precision tests. The results of the selectivity tests show that this method is selective, as no other drugs respond at the same time as isoniazid. Based on the validation parameters and the determination of isoniazid level, it was determined that the HPLC method may be used to determine the amount of isoniazid in the 2 FDC dispersible tablet formulation resulting from the dissolution test.
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