Development and Validation of a RP‐HPLC Method to Quantify Omeprazole in Delayed Release Tablets (original) (raw)
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Journal of Chromatographic Science, 2008
An accurate, simple, reproducible, and sensitive liquid chromatographic method is developed and validated to quantitate acyclovir (ACV) in cross-linked chitosan microspheres produced by spray drying. The analysis is carried out using a reversed-phase C 18 column with UV-vis detection at 254 nm. The mobile phase is diluted with pure water and acetonitrile (95:5 v/v) at a flow-rate of 0.8 mL/min. The parameters used in the validation process are: linearity, range, quantitation limit, detection limit, accuracy, specificity precision, and ruggedness. The retention time of acyclovir is approximately 3.5 min with symmetrical peaks. The linearity in the range of 1-10 µg/mL presents a correlation coefficient of 0.9999. The chitosan and the tripolyphosphate in the formulation do not interfere with the analysis, and the recovery is quantitative. Results are satisfactory, and the method proves to be suitable to quantitate ACV in cross-linked chitosan microspheres.
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 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 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.
Current Pharmaceutical Analysis
Background: Omeprazole has poor water solubility, is unstable in acidic solutions, and undergoes first pass metabolism which results in lowering its bioavailability. A solid Self-Nano Emulsifying Drug Delivery System (SNEDDS) was previously prepared to enhance its dissolution. Objective: Development and validation of a RP-HPLC method with UV detection for the determination of omeprazole in 0.1N HCl and in 0.01 M phosphate buffer (pH 7.4). Methods: Validation was according to the ICH Q2 (R1) guidelines in terms of linearity, accuracy and precision, lower limit of quantification, sensitivity, specificity, and robustness. The developed and validated method was used to study the in-vitro dissolution of the drug from the solid-SNEDDS, commercial products and of the unprocessed drug. The dissolution was studied in 500 ml of 0.1N HCl during the first 2 hours, and 900 mL of 0.01 M phosphate buffer (pH 7.4) during the last hour (37 ± 0.5 oC and 100 rpm). Results: The method was linear in the...
Research Journal of Pharmacy and Life Sciences, 2020
A reverse phase HPLC method was successfully developed and validated for concurrent assessment of omeprazole and aspirin for bulk and pharmaceutical formulation. The method was developed employing a reversed phase C 18 column. A optimized mobile phase having a composition of acetonitrile-methanol (20:80 v/v) was used. The experiment was carried out at flow rate of 0.6 ml/min and wavelength of 233 nm. Retention times for omeprazole and aspirin were found at 2.667 and 1.720 min respectively. Across a concentration span of 10-50 µg/ml and 5-25 µg/ml the method was linear for aspirin and omeprazole, respectively. The proposed method have potential for the regular quality scrutiny of this combination in bulk and pharmaceutical dosage form.
Journal of AOAC International
A method was optimized for the analysis of omeprazole (OMZ) by ultra-high speed LC with diode array detection using a monolithic Chromolith Fast Gradient RP 18 endcapped column (50 x 2.0 mm id). The analyses were performed at 30 degrees C using a mobile phase consisting of 0.15% (v/v) trifluoroacetic acid (TFA) in water (solvent A) and 0.15% (v/v) TFA in acetonitrile (solvent B) under a linear gradient of 5 to 90% B in 1 min at a flow rate of 1.0 mL/min and detection at 220 nm. Under these conditions, OMZ retention time was approximately 0.74 min. Validation parameters, such as selectivity, linearity, precision, accuracy, and robustness, showed results within the acceptable criteria. The method developed was successfully applied to OMZ enteric-coated pellets, showing that this assay can be used in the pharmaceutical industry for routine QC analysis. Moreover, the analytical conditions established allow for the simultaneous analysis of OMZ metabolites, 5-hydroxyomeprazole and omepraz...
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.
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, ...
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).