Entity

Time filter

Source Type

Hyderabad, India

Raghuram P.,Hetero Labs Ltd. | Raghuram P.,Krishna University | Soma Raju I.V.,Invagen Pharmaceuticals Inc | Soma Raju I.V.,Krishna University | Sriramulu J.,Krishna University
Chromatographia | Year: 2010

Gas chromatography with headspace injection technique has been developed for the quantification of diethylamine, triethylamine and cyclopropylamine in active pharmaceutical ingredients. The chromatographic separation is achieved on dimethylpolysiloxane oil coated capillary column with flame ionization detector. GC run time was 15 min employing programmed temperature with split mode headspace injection. The method is validated for specificity, linearity, accuracy, precision, and robustness. © 2010 Vieweg+Teubner Verlag | Springer Fachmedien Wiesbaden GmbH. Source


Satyanarayana R.P.,Hetero Labs Ltd.
Current Drug Discovery Technologies | Year: 2014

Objective: The research aims to formulate and develop the controlled release profile of glibenclamide by encapsulating glibenclamide into niosomes followed by incorporation into an aqueous gel base.Materials and Methods: Glibenclamide incorporated niosomes were prepared by a modified ether injection technique using Span 20/Span 80 and cholesterol. The prepared niosomes were evaluated for chemical incompatibility by FT-IR, morphology, vesicle dimension, encapsulation efficiency, in-vitro diffusion and drug release kinetics. Niosomal gels were prepared by incorporating the optimized niosomes into a gel base containing Carbopol 934 and evaluated for viscosity, in-vitro diffusion and in-vivo pharmacodynamic activity.Results and Discussion: The results indicated that relationship between the amount of Span and niosomal vesicular diameter was inversely proportional. Microscopic images have illustrated the sphere shape vesicles. The cumulative percentage of drug release from niosomal suspension was observed in the order GN-4>GN-2>GN-6>GN-5>GN-3>GN-1. Glibenclamide gel showed highest percentage drug release when compared to niosomal gel. Invivo study revealed that the glibenclamide incorporated niosomal gel formulation; GNG-1 is more efficient in lowering blood glucose levels in experimental animals.Conclusion: The niosomal gel of glibenclamide had released the drug in well controlled manner which is supported by pharmacodynamic activity with evidence of consistent lowering of blood glucose levels. © 2014 Bentham Science Publishers. Source


Vijaya Sri K.,Osmania University | Rohini P.,Osmania University | Kamalakar Reddy G.,Hetero Labs Ltd.
Asian Journal of Pharmaceutical and Clinical Research | Year: 2012

Objective: Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma. Fast dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/capsules etc. The present investigation was undertaken with the objective of formulating of the montelukast sodium fast dissolving oral thin films allowing fast reproducible drug dissolution in oral cavity thus bypassing first pass metabolism, to enhance the convenience and compliance by the elderly and pediatric patients. Materials and methods: Montelukast fast dissolving oral thin films were prepared by solvent casting method with using different film-forming agents like HPMC, PVP, PEG 400, glycerol as a plasticizer and mannitol as filler and sweetener. Oral thin films were evaluated for weight variation, thickness, surface pH, folding endurance, drug content, disintegration time, and invitro dissolution studies. Results: Montelukast oral thin films based on evaluation studies HPMC showed optimum performance against other formulations. The prepared films were clear, transparent, and had a smooth surface. Conclusion: It was concluded that the fast dissolving oral thin films of montelukast can be made by solvent casting technique with enhanced dissolution rate, better patient compliance and effective therapy. Source


Chilukuri M.,Hetero Labs Ltd. | Chilukuri M.,Krishna University | Narayanareddy P.,Hetero Labs Ltd. | Hussianreddy K.,Krishna University
Journal of Chromatographic Science | Year: 2014

A novel stability-indicating reverse-phase high-performance liquid chromatographic (HPLC) method has been developed for quantitative determination of Fosamprenavir Calcium, HIV-1 protease inhibitor. Chromatographic separationwas achieved using anYMCPack ODSAQ (150 mm 34.6 mm3 3.0 mm) HPLC column in isocratic mode employing 0.05 M Potassium dihydrogen orthophosphate monohydrate (pH 6.8) buffer and Acetonitrile in the ratio 60:40 (v/v) with a flow rate of 0.8 mL min21. Detector wavelength was monitored at 265 nm and column temperature was maintained at 408C. Fosamprenavir calcium was exposed to thermal, photolytic, humidity, water, acid, base and oxidative stress conditions. Considerable degradation of the drug substance was found to occur under acid, base and oxidative stress conditions. Peak homogeneity data of Fosamprenavir Calcium obtained by photodiode array detection demonstrated the specificity of the method in the presence of degradants. The degradation products were well resolved from the main peak of Fosamprenavir, indicating that the method is specific and stability-indicating. The HPLC method was validated as per International Conference on Harmonization guidelines with respect to specificity, precision, linearity, accuracy and robustness. Regression analysis showed a correlation coefficient value greater than 0.999. The accuracy of the method was established based on the recovery obtained for Fosamprenavir Calcium. © The Author [2013]. Source


Chilukuri M.,Hetero Labs Ltd. | Chilukuri M.,Krishna University | Hussainreddy K.,Krishna University | Narayanareddy P.,Hetero Labs Ltd. | Venkataramana M.,Hetero Labs Ltd.
Journal of Chromatographic Science | Year: 2014

Maraviroc is an antiretroviral drug in the CCR5 receptor antagonist class, which is used in the treatment of HIV. Maraviroc has six impurities. A novel, stability-indicating reversed-phase ultraperformance liquid chromatography (RP-UPLC) method has been developed for the quantitative determination of maraviroc in active pharmaceutical ingredients, along with its six impurities. The method is applicable to the quantification of related compounds and the assay of maraviroc. Efficient chromatographic separation was achieved on a BEH Shield RP-18 column, 100 × 2.1 mm, 1.7 μm, in isocratic elution within 12 min. The mobile phase was 0.01 M ammonium acetate in water and acetonitrile in the ratio of 63:37 (v/v). The flow rate was 0.4 mL/min, column oven temperature was maintained at 40°C and detection was conducted at 210 nm. Stress degradation conditions were established for maraviroc by subjecting it to acid, base, oxidation, water, humidity, thermal and photolysis stress. The stress samples were assayed against a qualified reference standard and the mass balance was close to 98.0%. The developed UPLC method was validated according to the current International Conference on Harmonization guidelines for specificity, detection limit, quantitation limit, linearity, accuracy, precision, intermediate precision and robustness. The resolution between maraviroc and its six impurities was greater than 3.0. A regression analysis showed that the correlation coefficient value was greater than 0.999 for maraviroc and its six impurities. © The Author [2013]. Published by Oxford University Press. All rights reserved. Source

Discover hidden collaborations