Partial Validation of High Performance Liquid Chromatography for Analysis of Isoniazid in Rat Plasma
Abstract: Tuberculosis is an
infectious disease caused by Mycobacterium tuberculosis. Nicotinic acid derivatives
such as isoniazid have the strongest anti-tuberculosis properties. For
pharmacokineticsstudying of isoniazid (INH), a method is needed to determine
the levels of INH in plasma. The aim ofthis research is to partial validate of
high performance liquid chromatography (HPLC) for analysis of INH in rat
plasma.For the preliminary study, rat plasma was used. The HPLC system used is
a stationaryphase C18 with length 250 mm and temperature of 30 °C, mobile phase
hexane sulphonate acid 20mM pH 2.47–methanol (65:35). The analytical parameters
in partial validated were linearity, lower limit ofquantifi cation (LLOQ),
precision, accuracy, and recovery. The results of linearity test of INH showedr
value of 0.9996. LLOQ of this methodwas 0.1258 μg/mL.The resulting accuracy and
precision value met FDA requirements with a percent recovery ranging from
96.57–107.99%. The HPLC system was a valid method for analysis of INH in rat
plasma.
Keywords: Isoniazid, high
performance liquid chromatography, rat plasma, partial validation
Penulis: NOVI YANTIH
Kode Jurnal: jpfarmasidd180055