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Ramesh, V.
- The Quantitative Determination of Process Related Genotoxic Impurities in Esomeprazole Magnesium by GC-MS
Authors
1 Matrix Laboratoires Ltd., R&D Centre, Jinnaram Mandal, Medak, 502325, IN
2 National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad, 500 007, IN
3 Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, IN
Source
Asian Journal of Research in Chemistry, Vol 4, No 6 (2011), Pagination: 898-901Abstract
A sensitive Gas chromatography-mass spectrometric (GC-MS) method is developed and validated for the determination of residuals 2-Chloromethyl-4-methoxy-3,5-dimethyl pyridine HCl (2), 2,3,5-Trimethyl pyridine Noxide (3), 4-Nitro-2,3,5-Trimethyl pyridine N-oxide (4) and 4-Methoxy-2,3,5-Trimethyl pyridine N-oxide (5) are genotoxic impurities in Esomeprazole magnesium (1) drug substance. Under the optimal conditions, the recovery for 2, 3, 4, and 5 are between 109.4% to 116.8%, 99.9% to 107.6%, 96.0% to 104.1%, and 87.4% to 105.2% for spiked samples at limits of quantification (LOQ) level in sample preparation. Limits of quantification (LOQ) and detection (LOD) are about 5 ppm and 1.5 ppm for the standard solutions of 2, 3, 4, and 5. The linearity values are 0.9989, 0.9968, 0.9988, and 0.9999 for 2, 3, 4, and 5. Based on these results, the method is applied to determine the residual genotoxic impurities are, 2-Chloro methyl-4-methoxy-3,5-dimethyl pyridine HCl (2), 2,3,5-Trimethyl pyridine Noxide (3), 4-Nitro-2,3,5-Trimethyl pyridine N-oxide (4) and 4-Methoxy-2,3,5-Trimethyl pyridine N-oxide (5) in Esomeprazole magnesium (1) drug substance.
Keywords
Esomeprazole Magnesium, Single Ion Monitoring, Gas Chromatography-Mass Spectrometry.- Validated Chromatographic Method for the Determination of Process Related Genotoxic Impurity in Lansoprazole
Authors
1 Matrix Laboratories Ltd., R&D Centre, Jinnaram, Medak, 502325, IN
2 National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad, IN
3 Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, IN
Source
Asian Journal of Research in Chemistry, Vol 4, No 6 (2011), Pagination: 965-967Abstract
An LC-MS method for the simultaneous determination of process related impurity of 2-Chloromethyl-3-methyl-4-(2, 2, 2-trifluoroethoxy) pyridine Hydrochloride (CMTP, 1) and RP-LC method for the routine determination of 1 in Lansoprazole (2) was presented. In LC-MS, Hypersil BDS C-18 (150 X 4.6 mm, 5 μm) column was used with mobile phase containing buffer (0.01 M ammonium acetate), acetonitrile, and methanol in 50:45:5 v/v ratios. The flow rate was 0.8 mL min-1 and elution was monitored at 205 nm. LC analysis of 1 was done on Synergi polar RP-80A (250 X 4.6 mm, 4 μm) column using mobile phase containing buffer (0.1% triethyl amine) and acetonitrile in 65:35 v/v ratio. The flow rate was 0.8 mL min-1 and elution was monitored at 205 nm. Both methods were validated as per International Conference on Harmonization (ICH) guidelines. LC-MS is able to quantitate up to 0.9 ppm, whereas with RP-LC up to 30 ppm of 1 could be quantitated.Keywords
Lansoprazole, Column Liquid Chromatography, Liquid Chromatography-Mass Spectrometry.- Synthesis and Evaluation of Some New Benzofuran Derivative for Antimicrobial Activity
Authors
1 Department of Pharmaceutical Chemistry, K.L.E. College of Pharmacy, K.L.E University, Belgaum-590010, IN
2 Department of Pharmaceutical Chemistry, V.L. College of Pharmacy, Raichur-584101, IN
Source
Asian Journal of Research in Chemistry, Vol 4, No 6 (2011), Pagination: 1009-1013Abstract
Most of the diseases in the current scenario are found to be due to infections caused by microbes like bacteria, fungi, rickettsia, etc. Many antibiotics have been discovered till date for treatment of such diseases but most of them are associated with superinfection, development of resistance, destruction of normal non pathogenic bacterial flora and selective toxicity like aplastic anemia, kidney damage etc. The present study is based upon preparation of antibiotics with high potency, specificity and less toxicity. Benzofuran derivatives are widely distributed in nature and they have been shown to have very interesting pharmacological activities like, antibacterial, anti-inflammatory and anti fungal. When one biologically active molecule is linked to another, the resultant molecule generally has increased potency. Hence in the present study the two pharmacophores, benzofuran and Mercaptotriazoles are fused to obtain highly potent, more specific and less toxic antibiotics.Keywords
Antifungal Activity, Antimicrobial Activity, Anti-Inflammatory, Anti-Depressant, Analgesic Activity, Hypoglycemic Activity.- A Sensitive and Selective GC-MS Method for the Determination of Process Related Genotoxic Impurities in Esomeprazole Magnesium
Authors
1 Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, IN
2 National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad-500007, IN
3 Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, IN
Source
Asian Journal of Research in Chemistry, Vol 3, No 2 (2010), Pagination: 395-397Abstract
A sensitive gas chromatography (GC)-mass spectrometry (MS) method is developed and validated for the determination of the residues p-Anisidine and 4-Methoxy-2-nitro aniline as genotoxic impurities in Esomeprazole magnesium drug substance.Keywords
GC-MS, Esomeprazole, Selected Ion Monitoring.- Low-Level Determination of Residual 4-Bromo Methyl-2'-Cyanobiphenyl in Valsartan by Liquid Chromatography-Mass Spectrometry
Authors
1 Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, IN
2 National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad-500007, IN
3 Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, IN
Source
Asian Journal of Research in Chemistry, Vol 3, No 2 (2010), Pagination: 407-410Abstract
A Liquid chromatographic (LC) method using mass spectrometric (MS) detection was developed and validated for the trace analysis (ppm level) of 4-Bromo methyl-2'-Cyanobiphenyl in Valsartan drug substances. LC analysis of 4-Bromo methyl-2'-Cyanobiphenyl was done on Necleosil C18 (100 mm×4.6 mm, 3 μm) column and the mobile phase is in the ratio of 50:50:1 containing water, acetonitrile, and acetic acid. The flow rate was 1.0 mL min-1 and the elution was monitored at 225 nm. The method was validated as per International Conference on Harmonization (ICH) guidelines. LC-MS is able to quantitate up to 1.0 ppm of 4-Bromo methyl-2'-cyanobiphenyl.Keywords
Liquid Chromatography, Mass Spectrometry Valsartan.- Simultaneous Spectroscopic Estimation of Amlodipine Besylate and Olmesartan Medoximil in Tablet Dosage Form
Authors
1 National Institute of Pharmaceutical Education and Research, Hyderabad-500 037, IN
2 National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad 500 007, IN
3 Pharmacology Division, Indian Institute of Chemical Technology, Hyderabad 500 007, IN