A Simple HPLC Method for the Determination of Omeprazole in Vitro (original) (raw)
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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, ...
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.
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.
Asian Journal of Pharmaceutical Research and Development
Omeprazole,13 a member of proton pump inhibitor, used for the treatment of peptic ulcers, it supresses gastric acid secretion by inhibiting H+/K+ ATPase. A new fundamental, rapid and sensitive HPLC method was developed for the assay of Omeprazole sodium for injection. It was validated according to ICH and FDA guidelines 2. The HPLC analysis was performed on Dionex ultimate 3000 system equipped with C-18 (150cm*4.6mm) 5µ column, with a mixture of ammonium acetate and acetonitrile buffer in the ratio 65:35 v/v as the mobile phase at the wavelength (λ) 305nm. The total run time was 8 minutes. The calibration curve was linear for 50-150% range of the analytical concentration of 40mg/ml, r2 was found to be 0.9998. The precision was calculated and % RSD was 0.1 % and the recovery of omeprazole was within the range of 98-102%. Validation parameters like robustness, solution stability studies, specificity and forced degradation studies were performed and found to be within acceptance limit...
International Current Pharmaceutical Journal, 2012
A method for the determination of omeprazole in bulk and capsule dosage form by reverse phase high performance liquid chromatography has been developed. This is a simple, rapid, precise and an accurate method. The method was developed on a Novapak C18, (250 x 4.6 mm, 5µ) column using phosphate buffer (pH 7.4) and acetonitrile in the ratio of 60:40, v/v as a mobile phase which was pumped at a flow rate of 1.0 ml/min and detection was done at 302 nm. The retention time of the drug was found to be 7.71 min. The method was validated for accuracy, precision, linearity, specificity, robustness. The linearity was observed in the range of 20-60 ppm. The results of recovery studies indicated that the method was accurate. Hence the developed method was found to be suitable for the estimation of omeprazole in bulk and capsule dosage forms.
Journal of Chromatography B: Biomedical Sciences and Applications, 1988
Omeprazole, 5-methoxy-2-[ [ (4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulphoxide] -lH-benzimidazole, is currently being investigated by the Digestive Disease Branch of the National Institute of Diabetes, Digestive and Kidney Diseases at the Clinical Center of the National Institutes of Health. Its use as an anti-ulcer agent in upper gastro-intestinal tract ulcers and in the treatment of the Zollinger-Ellison syndrome is being evaluated. It is believed omeprazole inhibits secretion of hydrochloric acid from the parietal cells of the stomach by selectively blocking the activity of the hydrogen-potassium ATPase system 037%4347/88/$#3.50 0 1988 Elsevier Science Publishers B.V.
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%.
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).
Kanpur Philosophers, 2022
The development and validation of a reverse-phase high-performance liquid chromatography (HPLC) technique for assessing omeprazole in bulk and aspirin in pharmaceutical formulations at the same time. During the validation process, the method's accuracy, precision, specificity, and robustness were tested from a variety of perspectives. Zydus Cadila Healthcare was the first company to manufacture and sell Burped Capsules. The capsules contain 20 milligrammes of omeprazole and 3 milligrammes of cinnarizine hydrochloride. On May 12, 2010, the Central Drugs Standard Control Organization of India granted them approval to manufacture and sell the product. Patients diagnosed with stomach ulcers, GERD, or dyspepsia who do not get relief from omeprazole treatment may be given a combination of two or more of these medications. The detection and quantitation limits for FEXO and MONT were 100.6079 ng/spot and 304.8726 ng/spot, respectively. The limit for MONT was 121.8456 ng/spot. An HPTLC approach has been devised and suggested for identifying and quantifying FEXO and MONT in bulk drug and drug formulation. This method may be used to analyse 145 both forms of the medication.
Improved high performance liquid chromatographic analysis of omeprazole in human plasma
A simple high-performance liquid chromatographic method was developed for the determination of omeprazole in human plasma. Omeprazole and the internal standard, chloramphenicol, were extracted from alkalinized plasma samples using dichloromethane. The mobile phase was 0.05 M Na 2 HPO 4 -ACN (65:35, v/v) adjusted to pH 6.5. Analysis was run at a flow rate of 1.0 ml/min at a detection wavelength of 302 nm. The method was specific and sensitive with a detection limit of 2.5 ng/ml at a signal-to-noise ratio of 4:1. The limit of quantification was set at 5 ng/ml. The calibration curve was linear over a concentration range of 5 -1280 ng/ml. Mean recovery value of the extraction procedure was about 96%, while the within and between day coefficient of variation and percent error values of the assay method were all less than 14%.