Jubilant Innovation

Yeshwanthpur, India

Jubilant Innovation

Yeshwanthpur, India

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Inamadugu J.K.,Sri Venkateswara University | Inamadugu J.K.,Wellquest Clinical Research Laboratory | Damaramadugu R.,Sri Venkateswara University | Damaramadugu R.,Wellquest Clinical Research Laboratory | And 2 more authors.
Biomedical Chromatography | Year: 2010

An LC-MS/MS method for the simultaneous quantitation of niacin (NA) and its metabolites, i.e. nicotinamide (NAM), nicotinuric acid (NUA) and N-methyl-2-pyridone-5-carboxamide (2-Pyr), in human plasma (1 mL) was developed and validated using nevirapine as an internal standard (IS). Extraction of the NA and its metabolites along with the IS from human plasma was accomplished using a simple liquid-liquid extraction. The chromatographic separation of NA, NAM, NUA, 2-Pyr and IS was achieved on a Hypersil-BDS column (150 x 4.6 mm, 5 μm) column using a mobile phase consisting of 0.1% formic acid : acetonitrile (20:80 v/v) at a flow rate of 1 mL/min. The total run time of analysis was 2 min and elution of NA, NAM, NUA, 2-Pyr and IS occurred at 1.37, 1.46, 1.40, 1.06 and 1.27 min, respectively. 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 100-20000 ng/mL for NA; 10-1600 ng/ mL for NUA and NAM and 50-5000 ng/mL for 2-Pyr with mean correlation coefficient of ≥0.99 for each analyte. The method was sensitive, specific, precise, accurate and suitable for bioequivalence and pharmacokinetic studies. The developed assay method was successfully applied to a pharmacokinetic study in humans. Copyright © 2010 John Wiley & Sons, Ltd.


Inamadugu J.K.,Sri Venkateswara University | Inamadugu J.K.,Wellquest Clinical Research Laboratory | Damaramadugu R.,Sri Venkateswara University | Damaramadugu R.,Wellquest Clinical Research Laboratory | And 2 more authors.
Biomedical Chromatography | Year: 2010

A simple, sensitive and rapid method has been developed and validated for determination of the metoclopramide (MCP) in 100 μL human plasma. The analytical procedure involves a liquid-liquid extraction method using tramadol as an internal standard (IS). Chromatographic separation was carried out on a HyPURITY ADVANCE column using a mobile phase consisting of acetonitrile and 10 mM ammonium acetate buffer in the ratio of 80:20 (v/v) at a flow rate of 0.3 mL/min. The total run time of analysis was 2.5 min and elution of MCP and IS occurred at 0.9 and 1.3 min, respectively. A linear response function was established for the range of concentrations 0.53-42.07 ng/mL (r > 0.99). The intra- and inter-day precision values for MCP met the acceptance as per FDA guidelines. MCP was stable in a battery of stability studies viz., bench-top, auto-sampler and freeze-thaw cycles. The developed assay method was successfully applied to an oral bioequivalence study in humans. Copyright © 2010 John Wiley & Sons, Ltd.


Hotha K.K.,Dr. Reddys Laboratories Ltd. | Hotha K.K.,Jawaharlal Nehru Technological University Anantapur | Ravindranath L.K.,A.P.S. University | Veera K.N.J.,Jawaharlal Nehru Technological University Anantapur | And 6 more authors.
Biomedical Chromatography | Year: 2010

A highly sensitive and specific LC-MS/MS method has been developed for simultaneous estimation of nortriptyline (NTP) and 10-hydroxynortriptyline (OH-NTP) in human plasma (250 μL) using carbamazepine as an internal standard (IS). LC-MS/MS was operated under the multiple reaction-monitoring mode using the electrospray ionization technique. A simple liquid-liquid extraction process was used to extract NTP, OH-NTP and IS from human plasma. The total run time was 2.5 min and the elution of NTP, OH-NTP and IS occurred at 1.44, 1.28 and 1.39 min, respectively; this was achieved with amobile phase consisting of 20 mM ammonium acetate : acetonitrile (20:80, v/v) at a flow rate of 0.50 mL/min on a HyPURITY C18 column. The developed method was validated in human plasma with a lower limit of quantitation of 1.09 ng/mL for both NTP and OH-NTP. A linear response function was established for the range of concentrations 1.09-30.0 ng/mL (r > 0.998) for both NTP and OH-NTP. The intra- and inter-day precision values for NTP and OH-NTP met the acceptance as per FDA guidelines. NTP and OH-NTP were stable in a battery of stability studies, i.e. bench-top, auto-sampler and freeze-thaw cycles. The developed assay was applied to a pharmacokinetic study in humans. Copyright © 2010 John Wiley & Sons, Ltd.


Suresh P.S.,Jubilant Biosys Ltd. | Giri S.,Jubilant Biosys Ltd. | Husain R.,Jubilant Biosys Ltd. | Mullangi R.,Jubilant Innovation
Biomedical Chromatography | Year: 2010

A highly sensitive, rapid assay method has been developed and validated for the estimation of S-citalopram (S-CPM) in rat plasma with liquid chromatography coupled to tandem mass spectrometry with electrospray ionization in the positive-ion mode. The assay procedure involves a simple liquid - liquid extraction of S-CPM and phenacetin (internal standard, IS) from rat plasma with t-butyl methyl ether. Chromatographic separation was operated with 0.2% formic acid:acetonitrile (20:80, v/v) at a flow rate of 0.50 mL/min on a Symmetry Shield RP18 column with a total run time of 3.0 min. The MS/MS ion transitions monitored were 325.26 → 109.10 for S-CPM and 180.10 → 110.10 for IS. Method validation and pre-clinical sample analysis were performed as per FDA guidelines and the results met the acceptance criteria. The lower limit of quantitation achieved was 0.5 ng/mL and the linearity was observed from 0.5 to 5000 ng/mL. The intra- and inter-day precisions were in the range of 1.14-5.56 and 0.25-12.3%, respectively. This novel method has been applied to a pharmacokinetic study and to estimate brain-to-plasma ratio of S-CPM in rats. Copyright © 2010 John Wiley & Sons, Ltd.


Mullangi R.,Jubilant Innovation | Ahlawat P.,ClinTec International | Srinivas N.R.,Integrated Drug Development
Biomedical Chromatography | Year: 2010

The introduction of irinotecan has revolutionized the applicability of camptothecins as predominant topoisomerase I inhibitor for anti-cancer therapy. The potent anti-tumor activity of irinotecan is due to rapid formation of an in vivo active metabolite, SN-38. Therefore, irinotecan is considered as a pro-drug to generate SN-38. Over the past decade, side-byside with the clinical advancement of the use of irinotecan in the oncology fi eld, a plethora of bioanalytical methods have been published to quantify irinotecan, SN-38 and other metabolites. Because of the availability of HPLC, LC-MS and LC-MS/ MS methods, the pharmacokinetic profi ling of irinotecan and its metabolites has been accomplished in multiple species, including cancer patients. The developed assays continue to fi nd use in the optimization of newly designed delivery systems with regard to pharmacokinetics to promote safe and eff ective use of either irinotecan or SN-38. This review intends to: fi rstly, provide an exhaustive compilation of the published assays for irinotecan, SN-38 and other metabolite(s) of irinotecan, as applicable; secondly, to enumerate the validation parameters and applicable conclusions; and thirdly, provide some recent perspectives in the clinical pharmacology arena pertaining to effl ux transporters, pediatric profi ling, role of kidney function in defi ning toxicity, drug-drug interaction potential of irinotecan, etc. Copyright © 2009 John Wiley & Sons, Ltd.


Venkatesh S.,JKK Nataraja Dental College and Hospital | Reddy B.M.,JKK Nataraja Dental College and Hospital | Reddy G.D.,JKK Nataraja Dental College and Hospital | Mullangi R.,Jubilant Innovation | Lakshman M.,Acharya N.G. Ranga Agricultural University
Journal of Natural Medicines | Year: 2010

The antihyperglycemic and hypolipidemic activities of Helicteres isora Linn. (Sterculiaceae) root extracts were investigated in alloxan-induced diabetic rats and a possible mechanism of the blood glucose lowering action was studied. Alloxan-induced diabetic rats experienced 69.13 and 51.14%, 22.60 and 21.89%, 30.12 and 19.96%, and 50.05 and 34.29% reduction in blood glucose, total cholesterol, triglycerides, and urea levels following oral administration of butanol and aqueous ethanol extracts of H. isora root, respectively, at 250 mg/kg for 10 days. The beneficial effects of these extracts were supported by evidence from histological examinations of the liver, pancreas, and kidney. Following the treatment with both extracts, the degenerative changes caused by alloxan in pancreatic cells were restored, particularly with the butanol extract. Histological examination convincingly showed the restoration of pancreatic islets, kidney glomeruli, and liver to its normal size. These results suggest that H. isora roots possess antidiabetic principles and can be useful for treatment of diabetes. © The Japanese Society of Pharmacognosy and Springer 2010.


PubMed | Jubilant Innovation
Type: Journal Article | Journal: Bioanalysis | Year: 2010

The emergence of bioanalysis as a key tool in the drug-discovery and -development process has enabled the development of sensitive, precise and specific bioanalytical methods in recent years. These methods have enabled the progress of novel chemical entities through the life cycle of drug discovery and development. The focus of this review article is on a well-known cholesteryl ester transfer protein (CETP) inhibitor known as torcetrapib. Although torcetrapib was withdrawn from clinical development, it is important to understand the various bioanalytical methodologies (chiral and achiral) that are readily available for the pharmacokinetic/pharmacodynamic characterization of the drug. Additionally, these methodologies may be applicable to the bioanalysis of the next-generation CETP inhibitors. This review covers the development and validation of assay methods that were used to obtain preclinical and clinical pharmacokinetic parameters of torcetrapib. Accordingly, methods are available for the determination of torcetrapib in various species, namely dogs, hamsters, rats, mice, monkeys and humans. Since torcetrapib is a chiral compound, methods have been developed for stereoselective bioanalysis to evaluate in vivo chiral inversion phenomena. Interestingly, torcetrapib can be analyzed by various bioanalytical options (e.g., HPLC-UV, LC-MS, LC-MS/MS and GC-MS assays) depending on the type of species under consideration with the associated sensitivity requirements. This review covers all the available methodologies for torcetrapib, providing both assay-development and -optimization strategies. It also tabulates validation parameters and enumerates the difficulties, challenges and nuances of the various published assays for torcetrapib.

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