Abstract

Establishing measurement of uncertainty for simultaneous bio-analytical method by LC-MS/MS

The objective of this activity is to evaluate the expanded uncertainty in the simultaneous bio-analysis of L-Carnitine, an endogenous compound and Metformin a biguanide which is used as treatment for T2DM. This simultaneous method is developed and validated using LCMSMS in human plasma[1]. This method is developed to establish a single method which can be used as the prognostic tool, TDM and for bio-analysis drug Metformin of T2DM. To use this method for bio-analysis and TDM it is validated as per ICH guidelines and found to be within the acceptance criteria. Using the precision data the combined uncertainty was calculated as per the GUM guidelines and the MOU for the method was established. Method was developed using the UFLCMS (Ultra Flow liquid chromatography mass spectrometer) for the simultaneous estimation of Metformin and L-Carnitine in human plasma with LOQ and ULOQ of 43.483ng/ml and 639.450 ng/ml for Metformin and 2.289µg/mL and 33.675 µg/mL for L-Carnitine respectively. Linearity was established by considering Concentration maximum for Metformin and normal value of L-Carnitine[1]. The precision data was used for evaluating the MOU as per GUM guidelines[2]. MOU was found to be ±1.89 for L-Carnitine and ± 0.9 7 for Metformin. MOU is needed to be considered for analysis and the validated data need is evaluated by applying the correction. As the MOU is established this method can be used as a prognostic tool and by calculating the systematic and random error the possible method error is evaluated.


Author(s): James D. Terish Bino, Kannappan, Sasi Jithand Suresh Kumar

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