A simple, specific, accurate and precise stability indicating reverse
phase high performance liquid chromatographic (RP-HPLC) method has been
developed for the simultaneous estimation of Aspirin and Isosorbide
5-mononitrate in bulk drug and its pharmaceutical dosage form. A
chromatographic separation was achieved with reverse phase phenomenex(R)
Luna 5µ C18 (2) 100A (250 × 4.60 mm) column in an isocratic mode at
ambient temperature. The mobile phase consisting of water: methanol:
acetonitrile (55:28:17% v/v/v) at a flow rate of 1 ml/min. The eluents
were monitored at 217 nm. The retention times of Aspirin and Isosorbide
5-mononitrate were found to be 2.05±0.056 min and 4.27±0.016 min
respectively. The regression analysis revealed linearity in the
concentration range of 1-10 µg/ml and 1-10 µg/ml for Aspirin and
Isosorbide 5-mononitrate respectively. The method was validated in terms
of linearity, accuracy, precision, limit of detection (LOD), limit of
quantification (LOQ) in accordance with ICH guide lines. The results of
the study showed that the developed method is simple, precise and
accurate, and therefore suitable for routine analysis of these drugs in
pharmaceutical dosage form.