Jubilant Biosys 2nd Stage

India

Jubilant Biosys 2nd Stage

India
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Suresh P.S.,Jubilant Biosys 2nd Stage | Srinivas N.R.,Suramus Bio Drug Development | Mullangi R.,Jubilant Biosys 2nd Stage
Biomedical Chromatography | Year: 2017

Prostate cancer is the most common cancer and one of the leading causes of cancer deaths in men. One of the commonly used approaches to treat metastatic prostate cancer was via first-generation nonsteroidal anti-androgens (NSAAs), namely flutamide, nilutamide, bicalutamide and topilutamide. Most prostate cancer patients who are initially responsive develop the most aggressive form of disease called castration-resistant prostate cancer. Second-generation NSAA receptor antagonists (enzalutamide, apalutamide and darolutamide) are emerging as additional new options to treat castration-resistant prostate cancer. The objective of this work was to review the literature on the bioanalytical methods for the quantification of first- and second-generation NSAA inhibitors in clinical (human plasma) and preclinical (mouse plasma, rat plasma, urine and tissue homogenates etc.) studies along with relevant case studies for some chosen drugs. Based on the review, it was concluded that the published methodologies using either HPLC or LC-MS/MS are well suited for the quantification of NSAA inhibitors in various biological fluids to delineate pharmacokinetic data. © 2017 John Wiley & Sons, Ltd.


Suresh P.S.,Jubilant Biosys 2nd Stage | Srinivas N.R.,Suramus Bio Drug Development I Phase | Mullangi R.,Jubilant Biosys 2nd Stage
Biomedical Chromatography | Year: 2016

Inhibition of dipeptidyl peptidase-4 (DPP4) is an emerging therapeutic approach for treating type 2 diabetes and has revolutionized the concept of diabetes management. Sitagliptin is the first approved orally active, potent, selective and nonpeptidomimetic DPP4 inhibitor. Incidence of hypoglycemia and weight gain is negligible with sitagliptin treatment. It is used as monotherapy or in combination with other anti-diabetic drugs to treat type 2 diabetes. There are numerous bioanalytical methods published for the analysis of sitagliptin in preclinical and clinical samples. This review focuses on the various HPLC and LC-MS/MS methods that have been used to analyze sitagliptin in various biological matrices. A small section is devoted to the bioanalysis of other DPP4 inhibitors such as vildagliptin, saxagliptin and linagliptin. This review provides key information in a concise manner regarding sample processing options, chromatographic/detection conditions and validation parameters of the chosen methods for sitagliptin and other DPP4 inhibitors. © 2016 John Wiley & Sons, Ltd.


Gilibili R.R.,Jubilant Biosys 2nd Stage | Kandaswamy M.,Jubilant Biosys 2nd Stage | Sharma K.,Jubilant Biosys 2nd Stage | Giri S.,Jubilant Biosys 2nd Stage | And 2 more authors.
Biomedical Chromatography | Year: 2011

A highly sensitive and specific LC-MS/MS method was developed for simultaneous estimation of acetyl co-enzyme A (ACoA) and malonyl co-enzyme A (MCoA) in surrogate matrix using n-propionyl co-enzyme A as an internal standard (IS). LC-MS/MS was operated under the multiple reaction-monitoring mode using the electrospray ionization technique. Simple acidification followed by dilution using an assay buffer process was used to extract ACoA, MCoA and IS from surrogate matrix and tissue samples. The total run time was 3min and the elution of both analytes (ACoA, MCoA) and IS occurred at 1.28min; this was achieved with a mobile phase consisting of 5mM ammonium formate (pH 7.5)-acetonitrile (30:70, v/v) delivered at a flow rate of 1mL/min on a monolithic RP-18e column. A linear response function was established for the range of concentrations 1.09-2187 and 1.09-2193ng/mL for ACoA and MCoA, respectively. The intra- and inter-day precision values for ACoA and MCoA met the acceptance as per FDA guidelines. ACoA and MCoA were stable in a battery of stability studies viz. bench-top, auto-sampler and long-term. The developed assay was used to quantitate ACoA and MCoA levels in various tissues of rat. © 2011 John Wiley & Sons, Ltd.

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