The present manuscript describes simple, sensitive, rapid, accurate and precise methods for the determination of Bosentan monohydrate in pharmaceutical dosage form. Method A is the second order derivative spectroscopic method and Method B is RP-HPLC method. In the Method A; the measurements were carried out at wavelengths of 251 nm. The method was found to be linear (r2>0.9997) in the range of 5-30 μg/ml at 251 nm. The limit of detection was 0.6417μg/ml. The limit of quantification was 1.944 μg/ml. In the Method B; the separation was carried out using mobile phase consisting of buffer (pH-2.5): methanol: acetonitrile (30:40:30 v/v). The column used was Inertsil-ODS-3, (150 mm x 4.6 mm i.d., 3 µm) with flow rate 1 ml/min using PDA detection at 273 nm. The method was linear over a concentration range 5-30 μg/ml. The retention time was found to be 5.18 min. Results of analysis were validated statistically and by recovery studies. The mean recovery was 99.98±0.81. The limit of detection (LOD) and the limit of quantification (LOQ) were found to be 0.2315 and 0.7017 µg/ml respectively. Both methods were successfully applied for estimation of Bosentan monohydrate in pharmaceutical dosage form. The results of both the studies showed that the proposed validated methods were found to be simple, sensitive, precise and accurate and also useful for the routine determination Bosentan monohydrate in tablet dosage form.
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