Analytical high performance liquid chromatography method for estimating the combination of aspirin and omeprazole in bulk and tablet dosage form (original) (raw)
Related papers
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 Pharmaceutical Research International
Aims: To study force degradation of aspirin and omeprazole simultaneously by RP-HPLC method Study design: RP-HPLC method was used to measure % degradation. Place and Duration of Study: Study was carried out at center of excellence, G.I.D.C., vapi-396195, Gujarat, India between June 2019 to march 2020. Methodology: A force degradation study of aspirin and omeprazole was carried out simultaneously. The drugs were subjected to various degradation conditions like hydrolysis by acid and base, Oxidative degradation, and thermal degradation study. Results: For acidic condition, the degradation was found to be 32.63 % for aspirin and 61.64 % for omeprazole. For basic condition, the degradation was found to be 10.17 % for aspirin and 4.29 % for omeprazole. By oxidative hydrolysis, the aspirin was degraded by 15.48 % and omeprazole was degraded by 26.38 %. By thermal degradation, 0.37 % degradation was observed for aspirin and 4.32 % degradation for omeprazole. Conclusion: In this proposed me...
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.
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.
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.
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.
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.
INDIAN DRUGS, 2020
The aim of the present work was to develop simple, precise and economic UV- spectrophotometric methods for the simultaneous estimation of aspirin and omeprazole in a laboratory sample. The absorbance maxima (λmax) for detection of aspirin and omeprazole were selected as 274 nm and 302 nm, respectively, for simultaneous equation method while wavelength range for detection of aspirin and omeprazole were selected as 270 nm - 276 nm and 300 nm - 305 nm, respectively for area under curve method. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ max of one of the two components. From the overlay spectra of two drugs, it is evident that aspirin and omeprazole show an isoabsorptive point at 238.6 nm. In zero crossing first derivative spectrophotometry, aspirin showed zero crossing point at 301nm and omeprazole showed zero crossing point at 274nm. Linearity for aspirin was between 25- 125 μg/mL and ome...
Journal of AOAC INTERNATIONAL, 2009
The development and validation of a column high-performance liquid chromatographic assay method for the determination of aspirin and clopidogrel in tablet formulation are described. The combination formulation was subjected to International Conference on Harmonization-recommended stress conditions. Separation of the drugs from the degradation products formed under stress conditions was achieved on an octasilyl (C8) column using 0.3 orthophosphoric acidacetonitrile (65 + 35, v/v) mobile phase. The method was validated for specificity, linearity, limits of detection and quantification, precision, accuracy, and robustness. The method was found to be specific against placebo interference and during the forced degradation. The response was linear in the concentration range of 30.0120.0 g/mL for aspirin and 15.060.0 g/mL for clopidogrel, with a correlation coefficient of 0.9999 for both. The relative standard deviation values for intra- and interday precision were <2.0. The accuracy wa...
International Journal of Pharmaceutical Chemistry and Analysis, 2023
The present study describes a new accurate and precise stability indicating reverse phase HPLC method for quantitative computation of pantoprazole sodium and Aspirin from physical simulated mixture. The proposed chromatographic method employs Hypersil ODS C18 column (250 x 4.6 mm, 5?) as the stationary phase and combination of methyl alcohol and water in ratio of 70: 30 v/v as the elution medium. Overall separation was carried out at 0.8 ml/minute flow rate and elution was monitored at 254 nm. The proposed system gave well resolved peak of Aspirin and Pantoprazole sodium with elution time of 2.32 and 5.85 minute respectively. Same system was effective in separation of active components and degradation products when the components were subjected to forced degradation as per regulatory guidelines (ICHQ1). Finally, the optimized method was successfully validated as per ICH Q2R1 guidelines and applied for quantitative analysis of both active components in synthetic mixture. Keywords: Validation, ICH, Aspirin, Pantoprazole sodium