Spectrophotometric determination of omeprazole, lansoprazole and pantoprazole in pharmaceutical formulations (original) (raw)
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A simple reversed-phase high performance liquid chromatography has been developed and employed for the analysis of Omeprazole and its related substances in bulk material and commercial dosage forms. A gradient elution of filtered sample was performed on Zorbax XDB C8 (150 x 4.6), 5µ column with Glacine buffer (pH -8.8) as a mobile phase-A, Acetonitrile : Methanol (83:17) as a mobile phase-B and UV detection at 302 nm. Mobile phase was delivered at flow of 1.2 mL/min and at maintaining the column temperature at 25ºC, quantification was achieved with reference to the external standards. The active ingredientomeprazole was successfully separated from its all related substances, including process impurities and other possible impurities of oxidation and decomposition. The excipients did not interfere with the determination of omeprazole and its related compound in commercial dosage formulations. The method was rapid, simple, accurate and reproducible. It was not only successfully employed for the assay of omeprazole in bulk material and pharmaceutical dosage forms but also for the determination of its related substances. A statistical design of experiments was used for the robustness evaluation of HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use.
Simple, fast and reliable spectrophotometric methods were developed for determination of Omeprazole in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 303 nm and the area under the curve method values measured at 300-305 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Omeprazole using 2-10μg/.ml (r²=0.9985 and r²=0.9959) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Omeprazole in tablets.
IJPSM, 2018
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).
Determination of omeprazole in pharmaceuticals by derivative spectroscopy
Journal of Pharmaceutical and Biomedical Analysis, 1997
A new derivative UV spectroscopic method was developed for the analysis of omeprazole in borate buffer (pH 10.0; 0.1 M). Second derivative spectra were generated between 200 -400 nm at N= 9, Du=31.5. The linearity range for values obtained from second derivative spectra was 0.2 -40.0 mg ml − 1 . The developed method was applied to five different commercial preparations of hard gelatin capsules containing enteric coated granules. The relative standard deviations were found to be 2.24% (brand A), 1.87% (brand B), 2.80% (brand C), 4.55% (brand D) and 1.09% (brand E). The data were compared with ones obtained from the polarographic method given in the literature and no difference was found statistically. © 1997 Elsevier Science B.V.
Asian Journal of Chemistry, 2015
Omeprazole is a widely used proton pump inhibitor prescribed for the treatment of dyspepsia, peptic ulcer disease, gastro esophageal reflux disease, laryngo pharyngeal reflux and Zollinger-Ellison syndrome. A new ultra performance liquid chromatographic (UPLC) method was developed and validated for the quantitative analysis of omeprazole in a capsule dosage form. The separation and analysis of the related drug in the presence of ondansetron as internal standard (IS) were performed on Waters UPLC BEH C18 column (50 mm × 2.1 mm i.d., 1.7 µm) using a mobile phase consisting of acetonitrile and 0.05 M H3PO4 (28:72 v/v). Flow rate of the used mobile phase was 0.28 mL/min. The retention time for omeprazole and internal standard was found to be 0.787 and 1.060 min, respectively. A calibration graph for omeprazole in the concentration range of 4-46 µg/mL was obtained by using peak area ratio of omeprazole and internal standard in their chromatogram obtained by the detection at 302 nm. In the method validation process, percent mean recovery and relative standard deviation was found as 101.6 % and 1.20 %, respectively. It was observed that the application of the newly developed UPLC method gave us successful results for the quantitative estimation of omeprazole in capsules.
Determination of omeprazole in bulk and injectable preparations by liquid chromatography
Journal of AOAC International
An accurate, simple, reproducible, and sensitive liquid chromatographic method was developed and validated for the determination of omeprazole in powder for injection and in pellets. The analyses were performed at room temperature on a reversed-phase C18 column of 250 x 4.6 mm id, 5 microm particle size. The mobile phase, composed of methanol-water (90 + 10, v/v), was pumped at a constant flow rate of 1.5 mL/min. Detection was performed on a UV detector at 301 nm. The method was validated in terms of linearity, precision, accuracy, and ruggedness. The response was linear in the range 32-48 microg/mL (r2 = 0.9976). The relative standard deviation values for intra- and interday precision studies were 1.22 and 1.56% for injectable and 2.13 and 2.45% for pellets, respectively. Recoveries ranged between 95.81 and 100.48%.
A Simple HPLC Method for the Determination of Omeprazole in Vitro
International Journal of Pharmaceutical Chemistry, 2013
Omperazole was used for the treatment of stomach and gastroesophageal reflux disease. Omperazole was used administered in the form of oral dose as independent or combination form. Â Presnt study was carried out to develop and validate a simple HPLC methtod of determination of omeprazole in vitro. Â Mobile phase empolyed was acetonitrile: phosphate buffer (65: 35), pH 6.8 and C 18 column was used. UV detector was used using 300nm eluted with the mobile phase 1.0 mint/ml.
To develop simple, economical, precise and less time consuming UV method for the estimation of Omeprazole in bulk and pharmaceutical formulations. The method is based on UV spectroscopic technique. Omeprazole shows the maximum absorbance at 301nm in absorption maxima method. Drug followed the linearity in the range of 5-25µg/ml for this method with correlation coefficient (r 2 ) of 0.999. The results of analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed method is recommended for routine analysis since it is rapid, simple, accurate and sensitive.
Dhaka University Journal of Pharmaceutical Sciences, 2010
A Simple RP-HPLC method with UV detection has been validated to determine omeprazole concentrations in human serum and urine samples. The mobile phase consisted of a mixture of potassium dihydrogen phosphate buffer (pH 7.2 ± 0.05; 0.2 M) and acetonitrile (70:30, v/v), pumped at a flow rate of 1.0 ml/min through the C-8 column at room temperature. Peaks were monitored by UV absorbance at 302 nm at a sensitivity of 0.0001. The developed method was selective and linear for omeprazole concentrations ranging between 5 to 1000ng/ml for serum samples and 1 to 100μg/ml for urine samples. The recovery of omeprazole ranged from 95.68 to 99% and 95.54 to 99.8% for the serum and urine samples respectively. The limit of quantitation (LOQ) of omeprazole was 5 ng/ml. The intraday accuracy ranged from 93.54 to 104.38% and 100.55 to 103.48% for the serum and urine respectively. The interday accuracy varied from 97.61 to 113.95% and 97.42 to 109.97% for the serum and urine respectively. For the LOQ, ...