Research Article

Development and Validation of a Chromatography Method Using Tandem UV/Charged Aerosol Detector for Simultaneous Determination of Amlodipine Besylate and Olmesartan Medoxomil: Application to Drug-Excipient Compatibility Study

Table 5

Recovery of AMLO and OLME after 3 and 6 months at 40°C ± 1°C under 75% ± 5% relative humidity in binary and ternary mixtures.

ExcipientBinary mixturesTernary mixtures
3 months6 months3 months6 months
AMLO (%)OLME (%)AMLO (%)OLME (%)AMLO (%)OLME (%)AMLO (%)OLME (%)

Corn starch99.3 ± 0.5102.4 ± 0.4104.3 ± 0.2107.1 ± 0.8101.7 ± 0.499.2 ± 0.999.2 ± 0.5110.1 ± 0.7
99.0 ± 0.5100.5 ± 0.774.2 ± 0.4102.5 ± 0.8100.5 ± 0.798.7 ± 0.982.7 ± 0.9101.5 ± 0.7
Microcrystalline cellulose102.3 ± 0.3100.4 ± 0.498.2 ± 0.4100.8 ± 0.5105.9 ± 0.998.2 ± 0.4101.7 ± 0.2101.2 ± 0.2
Croscarmellose sodium99.7 ± 0.8100.3 ± 0.599.8 ± 0.3102.6 ± 0.3103.2 ± 0.899.4 ± 0.692.3 ± 0.393.7 ± 0.5
Magnesium stearate100.8 ± 0.8101.6 ± 0.499.6 ± 0.6100.4 ± 0.699.0 ± 0.299.5 ± 0.481.2 ± 0.783.1 ± 0.7
Polyvinyl alcohol98.3 ± 0.998.5 ± 0.9100.7 ± 0.8102.9 ± 0.498.2 ± 0.6100.3 ± 0.284.4 ± 0.683.6 ± 0.2
Titanium dioxide98.1 ± 0.9100.6 ± 0.598.3 ± 0.499.9 ± 0.598.4 ± 0.698.1 ± 0.4101.8 ± 0.3104.3 ± 0.4
Talc99.9 ± 0.798.7 ± 0.6104.1 ± 0.5101.1 ± 0.399.4 ± 0.3100.5 ± 0.584.2 ± 0.479.5 ± 0.6
PVP98.1 ± 0.999.0 ± 0.798.2 ± 0.783.7 ± 0.9101.3 ± 0.7101.9 ± 0.475.2 ± 0.581.1 ± 0.9
Lactose monohydrate100.3 ± 0.6101.8 ± 0.673.7 ± 0.376.1 ± 0.698.9 ± 0.9101.3 ± 0.878.3 ± 0.874.2 ± 0.8
PEG99.1 ± 0.799.8 ± 0.5103.1 ± 0.398.2 ± 0.999.9 ± 0.599.1 ± 0.682.4 ± 0.786.9 ± 0.4