Bio-analytical method for insulin analogues
AssigneeBiocon Limited
InventorsMADHAVAN BUDDHA, MUKESH B. PATALE, ANAND KHEDKAR, RANITENDRANATH TAGORE, SEBASTIAN ALASTAIR MCDONALD
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Abstract
The present invention provides for a specific and sensitive bio-analytical method for detection of insulin or insulin analogues in plasma, serum or any other biological fluid, wherein the insulin or insulin analogues are labelled with a stable isotopic nitrogen for detection by the use of solid phase extraction and liquid chromatography with tandem mass spectrometric detection.
Claims19
method for detection and quantification of insulin or insulin analogue in a biological matrix wherein the method comprising the steps of:
- labelling known amount of insulin or insulin analogue by a stable isotope to form a labelled insulin or insulin analogue;
- ii. introducing the labelled insulin or insulin analogue to biological matrix;
- and
- iii. Analysing the biological matrix for intact insulin or insulin analogues by liquid phase chromatography-tandem mass spectrometry (LC-MS/MS).
A method for determining the stability of IN-105 insulin in a biological matrix comprising at least one additional type of insulin or an insulin analogue, the method comprising:
- i) labelling a known amount of IN-105 by a stable isotope of nitrogen to form a labelled IN-105;
- ii) introducing the labelled IN-105 to the biological matrix comprising the at least one additional insulin or insulin analogue;
- iii) subjecting the solution obtained from step ii) to a mixed-mode anion exchange-reverse phase solid phase extraction process using off-line solid-phase extraction (SPE) followed by on-line SPE in 96 well formation.
- iv) analysing the intact labelled IN-105 relative to that of the at least one additional type of insulin or insulin analogue by liquid phase chromatography-tandem mass spectrometry (LC-MS/MS).
Dependencies are inferred from the claim text.