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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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