Jubilant Biosys

Bangalore, India

Jubilant Biosys

Bangalore, India
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Pilli N.R.,Jawaharlal Nehru University | Mullangi R.,Jubilant Biosys | Inamadugu J.K.,Sri Venkateswara University | Rao N.S.,Andhra University
Biomedical Chromatography | Year: 2012

A simple, sensitive and specific LC-MS/MS method for simultaneous determination of simvastatin (SV), lovastatin (LV) and niacin (NIA) in human plasma was developed and validated on API-4000 in positive ion mode. Nevirapine was used as internal standard (IS). The assay procedure involved a simple one-step liquid-liquid extraction of SV, LV, NIA and the IS from plasma into ethyl acetate. Separation of SV, LV, NIA and the IS was achieved on an Alltima C 18 column with a mobile phase consisting of 5mm ammonium acetate (pH 4.5) and acetonitrile (20:80, v/v) pumped at a flow rate of 1mL/min. Nominal retention times obtained for SV, LV, NIA and IS were 2.12, 1.67, 0.50 and 0.65min, respectively. The lower limits of quantification (LLOQ) for SV, LV and NIA were 0.10, 0.10 and 25.2ng/mL, respectively. The response function was established for the range of concentrations 0.10-101ng/mL for SV and LV, and 25.2-5020ng/mL for NIA, with a coefficient of correlation of >0.99 for all the compounds. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. The proposed method was found to be applicable to clinical studies. © 2011 John Wiley & Sons, Ltd.


Kallem R.R.,Andhra University | Mullangi R.,Jubilant Biosys | Hotha K.K.,Sri Krishnadevaraya University | Hotha K.K.,Novel Laboratories Inc | And 2 more authors.
Bioanalysis | Year: 2013

Background: A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for simultaneous quantification of amlodipine (AMD) and atenolol (ATL) in human plasma (200 l) using AMD-d4 and ATL-d7, respectively, as an internal standard (IS) as per the regulatory guidelines. Results: The SPE method was used to extract the analytes and IS from human plasma. The chromatographic resolution of AMD, ATL and corresponding IS was achieved using an isocratic flow on a C18 column. The total chromatographic run time was 3 min. A linear response function was established for the range of concentrations 50-8000 pg/ml and 10-800 ng/ml for AMD and ATL, respectively, in human plasma. Conclusion: The intra- and inter-day accuracy and precision values for AMD and ATL met the acceptance as per regulatory guidelines. The validated assay was applied to a fixed-dose combination of AMD and ATL (Adopin-AT®) PK study in humans. © 2013 Future Science Ltd.


Kallem R.R.,Andhra University | Ramesh M.,Jubilant Biosys | Seshagirirao J.V.L.N.,Andhra University
Biomedical Chromatography | Year: 2013

A highly sensitive and specific LC-ESI-MS/MS method has been developed and validated for simultaneous quantification of felodipine (FDP) and metoprolol (MPL) in rat plasma (50μL) using phenacetin as an internal standard (IS) as per the FDA guidelines. Liquid-liquid extraction method was used to extract the analytes and IS from rat plasma. The chromatographic resolution of FDP, MPL and IS was achieved with a mobile phase consisting of 0.2% formic acid in water-acetonitrile (25:75, v/v) with a time program flow gradient on a C18 column. The total chromatographic run time was 4.0min and the elution of FDP, MPL and IS occurred at 1.05, 2.59 and 1.65min, respectively. A linear response function was established for the range of concentrations 0.59-1148 and 0.53-991ng/mL for FDP and MPL, respectively, in rat plasma. The intra- and inter-day accuracy and precision values for FDP and MPL met the acceptance as per FDA guidelines. FDP and MPL were stable in battery of stability studies viz., bench-top, auto-sampler and freeze-thaw cycles. The validated assay was applied to a pharmacokinetic study in rats. © 2013 John Wiley & Sons, Ltd.


Pilli N.R.,Jawaharlal Nehru University | Pilli N.R.,Wellquest Clinical Research | Inamadugu J.K.,Jawaharlal Nehru University | Mullangi R.,Jubilant Biosys | And 3 more authors.
Biomedical Chromatography | Year: 2011

A rapid, simple, sensitive and specific LC-MS/MS method has been developed and validated for the simultaneous estimation of atorvastatin (ATO), amlodipine (AML), ramipril (RAM) and benazepril (BEN) using nevirapine as an internal standard (IS). The API-4000 LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. Analytes and IS were extracted from plasma by simple liquid-liquid extraction technique using ethyl acetate. The reconstituted samples were chromatographed on C18 column by pumping 0.1% formic acid-acetonitrile (15:85, v/v) at a flow rate of 1mL/min. A detailed validation of the method was performed as per the FDA guidelines and the standard curves were found to be linear in the range of 0.26-210ng/mL for ATO; 0.05-20.5ng/mL for AML; 0.25-208ng/mL for RAM and 0.74-607ng/mL for BEN with mean correlation coefficient of ≥0.99 for each analyte. The intra-day and inter-day precision and accuracy results were well with in the acceptable limits. A run time of 2.5min for each sample made it possible to analyze more than 400 human plasma samples per day. The developed assay method was successfully applied to a pharmacokinetic study in human male volunteers. © 2010 John Wiley & Sons, Ltd.


Balaji G.A.,Molark Enterprises Pvt. Ltd. | Balaji V.N.,Jubilant Biosys | Rao S.N.,Rutgers University
Journal of Molecular Structure | Year: 2016

Factor XIa inhibitors have been identified to have potential as anticoagulants with robust efficacy and low bleeding risks. In light of their significance and the availability of their 3-D X-ray data in the PDB, we present molecular docking studies carried out with a view to obtain docking protocols that will successfully reproduce the experimentally observed protein-ligand interactions in the case of various X-ray ligands. In this context, we have specifically investigated the efficacy of various cross-docking protocols in reproducing experimental data. Our studies demonstrate that an ensemble of the three apo proteins is capable of accurately docking a majority of the X-ray ligands accurately without invoking any additional conformational flexibility than that present in their experimental structures. Further, we demonstrate that such an ensemble is successfully able to enrich a collection of known active factor XIa inhibitors embedded in a decoy database of drug-like molecules. © 2015 Elsevier B.V. All rights reserved.


Mullangi R.,Jubilant Biosys | Srinivas N.R.,Suramus Biopharm
Biomedical Chromatography | Year: 2013

Clinical investigations of choleteryl ester transfer protein (CETP) inhibitors are still underway owing to its promise of reducing risk factors in patients with cardiovascular disease. Although several CETP inhibitors have reached late phase clinical testing, there is a paucity of publications that describe the determination of various CETP inhibitors in human and/or animal matrices. An attempt is made in this review to collate bioanalytical information on three CETP inhibitors (anacetrapib, dalcetrapib and torcetrapib) and its metabolites, where data were available and reported. As elaborated in the review, owing to numerous structural issues coupled with chromatography/detection challenges indigenous to the class, a wide array of analytical tools, detection systems, interesting process manipulations and separation nuances have been utilized for the quantitative analysis of CETP inhibitors and applicable metabolites. Copyright © 2013 John Wiley & Sons, Ltd. © 2013 John Wiley & Sons, Ltd.


Gaudana R.,University of Missouri - Kansas City | Parenky A.,University of Missouri - Kansas City | Vaishya R.,University of Missouri - Kansas City | Samanta S.K.,Jubilant Biosys | Mitra A.K.,University of Missouri - Kansas City
Journal of Microencapsulation | Year: 2011

The objective of this study was to develop and characterize a nanoparticulate-based sustained release formulation of a water soluble dipeptide prodrug of dexamethasone, valinevaline-dexamethasone (VVD). Being hydrophilic in nature, it readily leaches out in the external aqueous medium and hence partitions poorly into the polymeric matrix resulting in minimal entrapment in nanoparticles. Hence, hydrophobic ion pairing (HIP) complexation of the prodrug was employed with dextran sulphate as a complexing polymer. A novel, solid in oil in water emulsion method was employed to encapsulate the prodrug in HIP complex form in poly(lactic-co-glycolic acid) matrix. Nanoparticles were characterized with respect to size, zeta potential, crystallinity of entrapped drug and surface morphology. A significant enhancement in the entrapment of the prodrug in nanoparticles was achieved. Finally, a simple yet novel method was developed which can also be applicable to encapsulate other charged hydrophilic molecules, such as peptides and proteins. © 2011 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.


Kethiri R.R.,Jubilant Biosys | Bakthavatchalam R.,Jubilant Biosys
Expert Opinion on Therapeutic Patents | Year: 2014

Introduction: Leucine-rich repeat kinase 2 (LRRK2) is a large (2527 residues) complex multi-domain protein that has GTPase and kinase domains. Autosomal dominant missense mutations in LRRK2 have been found in individuals with Parkinson's disease (PD) and are considered responsible for 1% of all cases of PD. Among the mutations confirmed to contribute to PD pathogenicity, G2019S is the most common cause of PD and it increases the kinase activity of LRRK2 by around threefold. LRRK2 has received considerable attention as a therapeutic target for PD, and LRRK2 inhibitors may help prevent and/or treat the disease.Areas covered: LRRK2 inhibitors are being investigated by various industrial and academic institutions. The present review covers patents literature on small-molecule LRRK2 inhibitors patented between 2011 and 2013.Expert opinion: Currently, wild-type and mutant LRRK2 are being examined as therapeutic targets for PD. In testimony to the significance of these novel targets, over 20 patent applications related to LRRK2 have been filed in the last 3 years. Several distinct chemotypes have been reported to be LRRK2 inhibitors with very good potency. These compounds are being used to elucidate the physiological and pathophysiological functions of LRRK2, and some may even emerge as therapeutics for PD. © 2014 Informa UK, Ltd.


Kallem R.R.,Andhra University | Inamadugu J.K.,Clinical Research Laboratories | Ramesh M.,Jubilant Biosys | Seshagirirao J.V.L.N.,Andhra University
Biomedical Chromatography | Year: 2013

A rapid, simple, sensitive and selective LC-MS/MS method has been developed and validated for quantification of nifedipine (NF) and atenolol (AT) in human plasma (250 μL). The analytical procedure involves a one-step liquid-liquid extraction method using carbamazepine as an internal standard (IS). The chromatographic resolution was achieved on a Hypurity Advance C18 column using an isocratic mobile phase consisting of 5 mm ammonium acetate-acetonitrile (15:85, v/v) at flow rate of 1.0 mL/min. The LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. The total run time of analysis was 2 min and elution of NF, AT and IS occurred at 0.79, 1.04 and 0.76 min, respectively. A detailed method validation was performed as per the FDA guidelines and the standard curves found to be linear in the range of 1.02-101 ng/mL for NF and 5.05-503 ng/mL for AT, with a coefficient of correlation of ≥0.99 for both the drugs. NF and AT were found to be stable in a battery of stability studies, viz. bench-top, auto-sampler and repeated freeze-thaw cycles. The validated assay method was successfully applied to a pharmacokinetic study in humans. © 2012 John Wiley & Sons, Ltd.


Sugasini D.,Indian Central Food Technological Research Institute | Devaraj V.C.,Jubilant Biosys | Ramesh M.,Jubilant Biosys | Lokesh B.R.,Indian Central Food Technological Research Institute
Lipids | Year: 2014

In the present study we evaluated the uptake of ALA and its conversion to EPA + DHA in rats given linseed oil (LSO) in native form or as a microemulsion in whey protein or in lipoid. In a single oral dose study in which rats maintained on rodent pellets deficient in ω-3 fatty acids were intubated with 0.35 g LSO in lipoid, the amount of ALA present in lymph was increased reaching a maximum concentration of 16.23 mg/ml at 2.5 h. The amount of ALA present in lymph was increased to a maximum level of 10.95 mg/ml at 4 h in rats given LSO as a microemulsion in whey protein. When LSO was given without emulsification, the amount of ALA present in lymph was found to reach a maximum level of 7.08 mg/ml at 6 h. A similar result was observed when weaning rats were intubated with 0.15 g of LSO per day for a period of 60 days. Higher levels of ALA by 41 and 103 % were observed in lymph lipids of rats given microemulsions of LSO in whey protein and in lipoid respectively as compared to rats given LSO without pre-emulsification. Very little conversion of ALA to EPA and DHA was observed in lymph lipids but higher amounts of EPA + DHA was observed in liver and serum of rats given LSO in microemulsion form. This study indicated that ALA concentration in lymph lipids was increased when LSO was given in microemulsion form in lipoid and further conversion to EPA and DHA was facilitated in liver and serum. © 2013 AOCS.

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