Development and Validation of Omeprazole Analysis Methods in Capsules with Absorbance Methods and Areas under Curves Methods with UV-Vis Spectrophotometry

Two simple spectrophotometric methods have been developed to analyse omeprazole in the capsule. This method uses sodium hydroxide 0.1 N as a solvent. The absorbance method was performed at a wavelength of 304.80 nm and the under-curve area method was performed at wavelengths between 281.60 nm-333.60 nm. The linearity of both methods was obtained at a concentration range of 10 μg / mL - 18 μg / mL. The absorbance method shows the correlation coefficient of 0.9998 and the area-under-curve method shows the correlation coefficient of 0.997. The percentage of generic omeprazole capsules with absorbance method was 105.48% and with the method of area under the curve was 102.87%. The percentage of omeprazole capsules of the trademark obtained by absorbance method was 104.02% and by the method of area under the curve was 103.62%. Percentage of both samples meets the requirements of Pharmacopoeia Indonesia edition V that is 90% -110%. The average per cent of recovery obtained from both samples with the absorbance method and the area under the curve satisfy the requirements of the validation parameter, i.e., 80% -120%. The relative standard deviation for both methods is <2%. Statistical analysis showed that between the absorbance method and the area under the curve did not differ significantly (sig. 2-tailed> 0.05).