A stability-indicating reverse phase–high performance liquid chromatography (RP–HPLC) method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C18 column Phenomenix (250 mm×4.6 mm, 5 μm) with a mobile phase consisting of 900 mL of HPLC grade methanol and 100 mL of water of HPLC grade. The pH was adjusted to 3.55 with acetic acid. The mobile phase was sonicated for 10 min and filtered through a 0.45 μm membrane filter at a flow rate of 0.5 mL/min. The detection was carried out at 249 nm and retention time of atazanavir sulfate was found to be 8.323 min. Linearity was observed from 10 to 90 μg/mL (coefficient of determination R2 was 0.999) with equation, y=23.427x+37.732. Atazanavir sulfate was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation, and the results showed that it was more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
A simple reverse phase HPLC method was developed for the simultaneous estimation of Amlodipine and Olmesartan in
bulk and tablet form. Chromatography was performed by isocratic reverse phase separation on a stainless steel column 4.6
x 150mm, symmetry column packed with octa decyl silane bonded to porous silica (C18) with particle size 5 micron with
mobile phase containing TEA Buffer of pH 3.0 and Acetonitrile in proportion of 25:75 respectively. The flow rate was 1.0
ml/ min and effluent was monitored at 258 nm. The retention times were 2.39 min and 3.33 min respectively. The standard
curve was linear over a working range of 05–35 µg/ml for both Amlodipine and Olmesartan and gave an average correlation
coefficient of 0.999, and 0.999 for Amlodipine and Olmesartan respectively. The limit of quantitation (LOQ) of this method
was 2µg/ml for Amlodipine and Olmesartan. The absolute recovery was 100% for Amlodipine and 100.3 for Olmesartan.
Degradation products produced as a result of stress studies did not interfere with the detection of Amlodipine and
Olmesartan and the assay can thus be considered stability-indicating.
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