Glenmark Pharmaceutical Ltd.


Glenmark Pharmaceutical Ltd.

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Fernandes F.,Berhampur University | Pande S.,Glenmark Pharmaceutical Ltd
Journal of Clinical and Diagnostic Research | Year: 2010

Current Good Manufacturing Practices (cGMP) consist of the regulations, guidelines and recommended practices issued by the FDA and other international regulatory authorities, as well as by the current industry practice. They form the basis for the production and the testing of pharmaceutical products that are safe and effective for human use. Regulatory publications are necessarily vague so that manufacturers have the opportunity to incorporate innovations into their products. Thus, the practitioners of cGMP must strive to be up to date on the latest innovations. cGMP compliance ensures that the products which are produced, meet specific requirements for identity, strength, quality, and purity.

Krishna M.,Glenmark Pharmaceutical Ltd | Sherikar A.,Glenmark Pharmaceutical Ltd | Kotulkar V.,Glenmark Pharmaceutical Ltd | Kottawar D.,Glenmark Pharmaceutical Ltd | Reddy R.,Glenmark Pharmaceutical Ltd
Der Pharmacia Lettre | Year: 2016

A rapid, accurate and precise Ultra Performance Liquid Chromatographic (UPLC) method was developed for generating an exhaustive In-Vitro Dissolution profiles of phenytoin sodium capsules in an Immediate Release formulations. The method has been validated. The method employs Waters UPLC system on Acquity BEH C18, 100 x 2.1mm, 1.7μm column with a flow rate of 0.3 mL/min using a mobile phase of 50-50% of Buffer and Acetonitrile. The UPLC was equipped with a UV-Visible Detector and the measurements were taken at 229nm. The immediate release formulations label claim were 300mg, 100mg, 50mg and 25mg for which the injection volume was appropriately selected. The total runtime for each injection was 2mins only with the retention time of the phenytoin peak at about 1.4mins.The method was validated for Linearity, Specificity, precision, Solution Stability and Accuracy. The method validation shows the linearity correlation 0.999. The intra and inter-day precision are within acceptance criteria. Phenytoin sodium dissolution shows the stability of sample and standard solution. The accuracy was within Limit and data was generated for In-vitro Dissolution studies of phenytoin sodium capsules and Tablets.

Khashi M.,Islamic Azad University at Mashhad | Davoodnia A.,Islamic Azad University at Mashhad | Prasada Rao Lingam V.S.,Glenmark Pharmaceutical Ltd.
Research on Chemical Intermediates | Year: 2015

Starting from 2-amino-1-methyl-4,5-diphenyl-1H-pyrrole-3-carbonitrile, the synthesis of some new tricyclic pyrrolo[3,2-e][1,2,4]triazolo[1,5-c]pyrimidines catalyzed by 4-(N,N-dimethylamino)pyridine (DMAP) is described. Room-temperature reaction of 2-amino-1-methyl-4,5-diphenyl-1H-pyrrole-3-carbonitrile with triethyl orthoesters afforded the corresponding imidic esters. Treatment of these compounds with hydrazine hydrate at room temperature gave 4-imino-3H-pyrrolo[2,3-d]pyrimidin-3-amines, which were subsequently cyclized to the titled compounds on heating with acyl chlorides in the presence of DMAP as catalyst under solvent-free conditions. All synthetic compounds were characterized on the basis of their spectral and microanalytical data. The NOE and NOESY experiments on one of the final products show that no Dimroth rearrangement has occurred in compounds 4-imino-3H-pyrrolo[2,3-d]pyrimidin-3-amines under the reaction conditions. © 2014 Springer Science+Business Media.

Prasada Rao Lingam V.S.,Glenmark Pharmaceutical Ltd | Dahale D.H.,Glenmark Pharmaceutical Ltd | Mukkanti K.,Jawaharlal Nehru Technological University | Gopalan B.,Glenmark Pharmaceutical Ltd | Thomas A.,Glenmark Pharmaceutical Ltd
Tetrahedron Letters | Year: 2012

An efficient two-step approach for the synthesis of naphtho[1,2-b]furans and naphtho[2,1-b]furans has been developed. Various functionalized propargyl alcohols were etherified with α- or β-naphthol under Mitsunobu reaction conditions to give naphthyl 2-propynyl ethers, which underwent a facile microwave-assisted Claisen rearrangement and concomitant anionic cyclization to yield naphthofuran derivatives under basic reaction conditions. © 2012 Elsevier Ltd. All rights reserved.

Dhir N.K.,Ravishankar College | Dhir N.K.,Glenmark Pharmaceutical Ltd. | Yadav S.K.,Ravishankar College
Journal of the Indian Chemical Society | Year: 2012

An ultra performance liquid chromatographic (UPLC) method was developed for simultaneous determination of antifungal ointment and active pharmaceutical ingredient (API) residues. A new, generic method is presented, with which it is possible to verify the cleaning process of antifungal drug producing equipment line used for the production of various pharmaceuticals. The UPLC method was validated using an UPLC (BEH C18) column with a particle size of 1.7u (50 mm x 2.1 mm) and methanol-buffer (80:20, v/v) as mobile phase at a flow rate of 0.4 ml/min. Method development and method validation for cleaning control analysis are described. The rapid UPLC method is suitable for cleaning control assays within good manufacturing practices (GMP) of the pharmaceutical industry.

Krishna M.,Glenmark Pharmaceutical Ltd | Nadre M.,Glenmark Pharmaceutical Ltd | Sherikar A.V.,Glenmark Pharmaceutical Ltd | Reddy R.,Glenmark Pharmaceutical Ltd
International Journal of PharmTech Research | Year: 2015

Phenytoin, approved by the Food and Drug Administration in 1999 as a sedative for use in the intensive care unit, is a potent and highly selective α2-adrenoceptor agonist with significant sedative, analgesic and anxiolytic effects mostly used in the intensive care units. This article describes validation for the determination of related substances of Phenytoin Sodium in Phenytoin Sodium Capsules by usinga high performance liquid chromatography.The high performance liquid chromatography resolution was achieved on an Inertsil ODS 3, 150 × 4.6mm, 5μm, column with an gradient elution at a flow rate of 1.0 mL/min using a mobile phase A as buffer and mobile phase B as acetonitrile. The detection was performed by a photo diode array Detector. The method was validated in the concentration range of Limit of quantitation to 150% of working concentration. The intra and inter-day precision and accuracy were within Limit (10 % Relative Standard Deviation). The overall mean recoveries of Phenytoin were 97.5% for Limit of Quantitation and 95.6 % for 50% to 150%. © 2015, Sphinx Knowledge House. All right reserved.

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