Tag: 300-400

On December 31, 2013, Manranjan, Vayeda Chintan; Yadav, Devendra Singh; Jogia, Hitesh Amrutlal; Chauhan, Praful Lalitkumar published an article.Formula: C17H19N3O2S The title of the article was Design of experiment (DOE) utilization to develop a simple and robust reversed-phase HPLC technique for related substances’ estimation of omeprazole formulations. And the article contained the following:

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 (volume/volume)] and mobile phase B [acetonitrile: MeOH; 65:35 (volume/volume)]. The chromatog. 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 anal. of DOE with a 95% confidence interval (CI) confirmed the buffer pH of mobile phase A and column temperature as significant Critical Method Parameters (CMPs). The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Formula: C17H19N3O2S

The Article related to omeprazole impurity determination rp hplc, anova, chromatography, compatible, doe, hplc/uplc, method development, related substances, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Formula: C17H19N3O2S

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

Berzas Nevado, Juan Jose; Castaneda Penalvo, Gregorio; Rodriguez Dorado, Rosa M.; Rodriguez Robledo, Virginia published an article in 2013, the title of the article was Study of controlled degradation processes and electrophoretic behaviour of omeprazole and its main degradation products using diode-array and ESI-IT-MS detection.Safety of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole And the article contains the following content:

This paper provides chem. information of controlled degradation processes on omeprazole, and its main degradation products in aqueous solutions, using CE as the anal. technique. Both diode-array and ESI-IT-MS were employed as detectors to generate anal. data of the drugs studied. This information could be used to determine potential impurities for pharmaceuticals of omeprazole because it may influence not only the therapeutic efficacy but also the safety of active pharmaceutical ingredients. For this purpose, a new capillary zone electrophoresis method using diode-array detection for the simultaneous determination of omeprazole and its main degradation products was developed. Some different less aggressive degradation processes were studied, the fastest of which was found to be that of omeprazole in aqueous solutions exposed to UV light (254 nm). Using a background electrolyte (10 mM phosphate buffer, pH 12) the analytes were determined in < 6 min. Electrophoretic behavior using an optical detector revealed the presence of 7 products under the different exptl. conditions used. More anal. chem. information was obtained on omeprazole degradation products using direct infusion electrospray ionization-mass spectrometry operating in neg. ion mode [M - H]-, and even some chem. structures of omeprazole degradation products were proposed. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Safety of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

The Article related to omeprazole degradation determination capillary zone electrophoresis impurity, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Safety of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

On October 31, 2009, Iuga, Cristina; Bojita, Marius; Leucuta, Sorin E. published an article.COA of Formula: C17H19N3O2S The title of the article was Development of a validated RP-HPLC method for separation and determination of process-related impurities of omeprazole in bulk drugs. And the article contained the following:

A gradient reversed phase liquid chromatog. (RP-LC) method was developed and subsequently validated for the determination of omeprazole and its process-related impurities (noted as: impurity A, B, C, D, G, H). Separation was achieved with a Zorbax Extend C18 column and acetonitrile: water: triethylaminel percent (pH adjusted to 9.5) as eluent, at a flow rate of 0.8 mL/min. UV detection was performed at 280 nm. The described method was linear over a range of 40.6-203 μg/mL for omeprazole, 0.9556-14.334 μg/mL for impurity A, 1.1568-17.352 μg/mL for impurity B, 1.0772-16.158 μg/mL for impurity C, 1.289-19.344 μg/mL for impurity D, and 0.7968-11.952 μg/mL for impurity H. The accuracy of the method was demonstrated at 5 concentration levels in the range of 60-140% of the specification limit and the recovery of impurities was found to be in the range of 90-109%. The method is simple, rapid, selective, accurate, and useful for indicating the stability of omeprazole from dosage forms. The method can be useful in the quality control of bulk manufacturing and pharmaceutical formulations. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).COA of Formula: C17H19N3O2S

The Article related to omeprazole impurity separation determination rp hplc stability quality, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.COA of Formula: C17H19N3O2S

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

Hafez, H. M.; Elshanawany, A. A.; Abdelaziz, L. M.; Mohram, M. S. published an article in 2015, the title of the article was Stability indicating HPLC method for drugs indicated for helicobacter pylori-associated ulcers.Quality Control of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole And the article contains the following content:

Triple therapy regimen that comprises a proton pump inhibitor likes Omeprazole, antibiotics like Doxycycline and Tinidazole can be used for treatment of peptic ulceration which is caused by H. pylori. A validated HPLC method was developed as a stability-indicating HPLC method for these drugs and its impurities. New method overcame interference between Doxycycline and its epimer on achiral column by using a chiral mobile phase. The method was performed on Phenomenex BDS HYPERSIL C18 5 μm 100A (250×4.6 mm) and the mobile phase consisted of (1S)-(+)-Campher-10-sulfonic acid (0.01M) and Edetate disodium (0.001M) (pH=4.5) Acetonitrile which pumped at a flow rate 1.2 mL/min in gradient manner at 40°C. 20 μl of drugs sample solutions were monitored at wavelength 310 nm. Tinidazole, Doxycycline and Omeprazole and Trio capsule bulk powders were stressed under different conditions in forced degradation studies. Method validation was developed following the recommendations for anal. method validation of International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) organizations. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Quality Control of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

The Article related to helicobacter ulcer omeprazole doxycycline tinidazole stability hplc, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Quality Control of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

Nagavi, Jinesh Bahubali; Gurupadayya, Bannimath published an article in 2017, the title of the article was Stability-indicating UFLC method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using PDA detection.Synthetic Route of 73590-85-9 And the article contains the following content:

Introduction: In this paper a fast and novel stability-indicating ultra fast LC method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed and validated according to ICH guidelines. Methodol.: The separation of USP related substances of clopidogrel (A, B and C), aspirin (D), omeprazole (A, B and C) and few other unknown impurities was detected by using ultra fast liquid chromatog. with PDA detection. The maximum detection was set as follows: 237 nm for aspirin, its impurities and for the impurity C of clopidogrel and 254 nm for Clopidogrel and its impurities except for impurity C and 280 nm for omeprazole and its impurities. Phenomenex C8 (250 mm × 4.6 mm, 5 μ) was used as a stationary column to sep. and analyze the mixture within 11 min with a programmed gradient elution of 0.01 M phosphate buffer pH 2.0 and acetonitrile. The tablets were exposed to acid, alk., thermal, higher humidity, oxidative and photolytic stress conditions. Samples undergone stressed conditions were analyzed by the novel proposed method. Results: The method was successfully validated in accordance to the International Conference of Harmonization (ICH) guidelines for clopidogrel and its impurities, aspirin and its impurity D and omeprazole and its impurities A, B and C. Separation was satisfactory for all the significant degradation products from the principal peaks of drug substances and the impurities from each other. Conclusion: The method complies for the peak purity test for clopidogrel, aspirin and omeprazole in all the samples under stress and showed no co-elution of degradation products. The method was found to be stable, precise, linear, accurate, sensitive, specific and robust. The method can be used routinely to test the adulteration in the pharmaceutical formulations of clopidogrel, aspirin, and omeprazole. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Synthetic Route of 73590-85-9

The Article related to clopidogrel aspirin omeprazole tablet photodiode array uflc, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Synthetic Route of 73590-85-9

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

On September 5, 2010, Zanitti, Leo; Ferretti, Rosella; Gallinella, Bruno; La Torre, Francesco; Sanna, Maria Luisa; Mosca, Antonina; Cirilli, Roberto published an article.Recommanded Product: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole The title of the article was Direct HPLC enantioseparation of omeprazole and its chiral impurities: Application to the determination of enantiomeric purity of esomeprazole magnesium trihydrate. And the article contained the following:

Anal. and semipreparative high-performance liquid chromatog. (HPLC) enantioseparation of the proton-pump inhibitor omeprazole (OME) and its potential organic chiral impurities were accomplished on the immobilized-type Chiralpak IA chiral stationary phase (CSP) under both polar organic and normal-phase conditions. The (S)-enantiomers were isolated with a purity of >99% ee and their absolute configuration was empirically assigned by CD spectroscopy. A chemo- and enantioselective HPLC method was validated to control the enantiomeric purity of the (S)-enantiomer of OME (ESO), an active ingredient contained in drug products, in the presence of chiral and achiral related substances. The precision, linearity and accuracy of the determination of the (R)-impurity as well as the recovery of ESO from a pharmaceutical preparation were determined The proposed method uses the mixture Me tert-butylether (MtBE)-Et acetate (EA)-EtOH (EtOH)-diethylamine (DEA) 60:40:5:0.1 (volume/volume/volume/volume) as a mobile phase. In these conditions, linearity over the concentration range 0.5-25 μg/mL for (R)-enantiomer was obtained. The limits of detection and quantification were 99 and 333 ng/mL, resp. The intra and inter-day assay precision was <2% (RSD%). The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Recommanded Product: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

The Article related to omeprazole impurity determination hplc enantioseparation, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Recommanded Product: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

On September 30, 2010, Trivedi, Harshal K.; Patel, Mukesh C. published an article.COA of Formula: C17H19N3O2S The title of the article was Development and validation of a precise single HPLC method for determination of omeprazole and its related compound in pharmaceutical formulation. And the article contained the following:

A simple reversed-phase high performance liquid chromatog. was developed and employed for the determination of omeprazole and its related substances in bulk material and com. dosage forms. A gradient elution of filtered sample was performed on Zorbax XDB C8 (150 × 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 25°C, quantification was achieved with reference to the external standards The active ingredient – omeprazole 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 com. 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 anal. method. All results were acceptable and confirmed that the method is suitable for its intended use. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).COA of Formula: C17H19N3O2S

The Article related to omeprazole determination impurity reversed phase hplc, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.COA of Formula: C17H19N3O2S

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

Mahesh, H. R. K.; Babu, K. Sudhakar; Ram Prasad, Lanka A.; Pamidi, Srinivasu published an article in 2015, the title of the article was Simultaneous estimation of related compounds in Esomeprazole and Naproxen tablets by using ion pair reverse phase HPLC.Safety of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole And the article contains the following content:

Objective: To develop and validate a novel gradient reverse phase HPLC method for quant. estimation of Naproxen and Esomeprazole impurities in pharmaceutical dosage form. Methods: Chromatog. separation was achieved on X-Bridge C18,150 × 4.6 mm, 3.5 μm column. Detection wavelength was set at 302 nm. The mobile phase A consists of Buffer and Acetonitrile in the ratio of 90:10, where Buffer was prepared by dissolving di ammonium hydrogen phosphate (2.64 gm per L) and 1-hexane sulfonic acid sodium salt (1.0 gm per L), pH adjusted to 6.5±0.05 with orthophosphoric acid. A mixture of acetonitrile and 1-propanol in the ratio of 90:10 was used as mobile phase B. Flow rate was set to 0.7 mL/min in gradient elution mode, with a retention time for Naproxen and Esomeprazole 29 and 46 min resp. Results: The calibration curve was linear over the concentration range of 4.621 μg/mL-99.026 μg/mL for Naproxen and 0.254 μg/mL-3.806 μg/mL for Esomeprazole (r = 0.999). The proposed method was found to be (considered)accurate and precise and linear within the desired range. The limit of quantitation (LOQ) was calculated The purity angle was found less than purity threshold for forced degradation peaks, which shows there was no interference from the common excipient, known impurities and degradents indicating separation, accuracy and reliability of the method. The method was validated as per ICH guidelines and found to be specific, accurate, linear, precise and stability indicating. Conclusion: A Novel, simple, selective and rapid reversed phase high performance liquid chromatog. (HPLC) method was developed and validated for the estimation of Naproxen and Esomeprazole impurities in pharmaceutical dosage form. Hence, the method can be used for routine anal. in various pharmaceutical industries. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Safety of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

The Article related to esomeprazole naproxen tablet reverse phase hplc, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Safety of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

On September 30, 2014, Schmidt, Alexander H.; Stanic, Mijo published an article.COA of Formula: C17H19N3O2S The title of the article was Rapid UHPLC method development for: omeprazole analysis in a quality-by-design framework and transfer to HPLC using chromatographic modelling. And the article contained the following:

The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatog. (UHPLC) method for omeprazole and its related impurities. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).COA of Formula: C17H19N3O2S

The Article related to ultrahigh pressure liquid chromatog omeprazole, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.COA of Formula: C17H19N3O2S

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem

Dong, Qixin; Zhu, Jiajun; Sui, Qiang; Tang, Chao; Wang, Xiaomei; Yu, Yunqiu published an article in 2013, the title of the article was Optimization of mobile phase for the determination of Esomeprazole and related compounds and investigation of stress degradation by LC-MS.Application In Synthesis of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole And the article contains the following content:

In this study, the objective was to investigate the degradation behavior of Esomeprazole under different recommended stress conditions according to International Conference on Harmonization of Tech. Requirements for Registration of Pharmaceuticals for Human Use [1] by HPLC. Our research showed that the effect of mobile phase species on separation was significant for the determination of Esomeprazole and its related compounds Successful separation of the drug from its related impurities and degradation products formed under different stress conditions was achieved using ammonium acetate buffer/ACN by a gradient elution. Compared with phosphate buffer/ACN, ammonium acetate buffer/ACN under same pH and gradient showed a great improvement in resolution due to the change of elution order. The drug was subjected to stress conditions including acidic, alk., oxidative, photolytic, and thermal conditions. Extensive degradation occurred in acidic and oxidative conditions, while mild degradation was observed in alk. and photolytic conditions. Besides, it turned out the drug was extremely stable under thermal condition. The stability-indicating LC-UV method was validated with respect to linearity, precision, accuracy, specificity, and robustness. The LC-MS method was also adopted for the characterization of degradation products. Based on the m/z values and fragmentation patterns, the degradation pathway of the drug has been proposed. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).Application In Synthesis of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

The Article related to esomeprazole stress degradation product lc ms, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.Application In Synthesis of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole

Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem