METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF OMEPRAZOLE AND CINITAPRIDE IN PURE FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC (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.
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 Research in Pharmacy, 2018
A HPLC method was developed for the estimation of aspirin and omeprazole simultaneously in bulk drug and tablet dosage forms. 0.1 M potassium dihydrogen phosphate and acetonitrile in the ratio of 55:45 v/v at pH of 4.5 was used successfully as the mobile phase for the analysis of the selected drugs. Analysis of the selected drugs was carried out using Zodiac C18 (150 × 3.0 mm, 5 µm) column. The calibration range for omeprazole was 0.08-24 µg/ml, whereas, for aspirin was 0.65-195 µg/ml. The LOD and LOQ values were; 0.199 μg/ml and 0.65 μg/ml for aspirin, 0.024 μg/ml and 0.080 μg/ml for omeprazole, respectively. The percentage recovery of aspirin and omeprazole was found to be 99.75%-99.92% and 99.46%-99.57%, respectively. Percentage relative standard deviation (RSD%) was found to be in the range of 0.083%-0.085% for aspirin and 0.045%-0.047% for omeprazole. Forced degradation studies (such as alkaline, acidic, oxidative, thermal and photolytic degradation conditions) were performed on tablet sample as per the ICH guidelines. The peaks of degradants are well separated from the main peaks of aspirin and omeprazole. The proposed HPLC method was successfully applied for the quantification of aspirin and omeprazole in its pharmaceutical dosage forms without interference from common excipients.
INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY, 2012
An accurate, Precise, Simple and Economical High Performance Liquid Chromatographic method for the estimation of Omeprazole and Cinitapride was developed and validated. The determination was performed by the using of two phases one is stationary phase it’s a Thermo BDS Hypersil C18 column having 250 x 4.6mm 5μ, and another one is mobile phase containing 0.1N phosphate buffer and Acetonitrile at the ratio 50:50%v/v. The flow rate was 1ml/min and effluents were monitored at 282nm. The retention time of Omeprazole and Cinitapride was 3.5 and 5.4 min respectively. The developed method was validated for specificity, system suitability, precision, linearity, accuracy, Limit of Detection, Limit of Quantification, robustness, and ruggedness. Recovery of Omeprazole and Cinitapride in formulations was found to be in the range of 99%, 100%, and 101% respectively. And the correlation coefficient was 0.999. Hence, it was concluded that the developed method is suitable for routine analysis of these combination due to its less analysis time.
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.
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).
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.
Development and Validation of a RP‐HPLC Method to Quantify Omeprazole in Delayed Release Tablets
Journal of Liquid Chromatography & Related Technologies, 2007
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.
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.
Scientia pharmaceutica, 2013
A simple, fast, and sensitive reversed-phase HPLC method with UV detection was developed for the quantitation of omeprazole and its eleven related compounds (impurities) in pharmaceutical formulation using the Thermo Accucore C-18 (50 mm × 4.6 mm, 2.6 μm) column. The separation among all the compounds was achieved with a flow rate of 0.8 mL min(-1) employing a gradient program of mobile phase A [0.08 M glycine buffer pH 9.0: acetonitrile; 95:05 (v/v)] and mobile phase B [acetonitrile: methanol; 65:35 (v/v)]. The chromatographic detection was carried out at a wavelength of 305 nm. The method was validated for specificity, linearity, and recovery. The huskiness of the method was determined prior to validation using the Design of Experiments (DOE). The ANOVA analysis of DOE with a 95% confidence interval (CI) confirmed the buffer pH of mobile phase A (p <0.0001) and column temperature (p<0.0001) as significant Critical Method Parameters (CMPs).