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Development and Validation of an LC-MS/MS Method for Simultaneous Determination of Canagliflozin and Metformin HCl in Rat Plasma and its Application

Author(s):

Vivek Nalawade*, Vaibhav Dixit, Amisha Vora and Himashu Zade   Pages 1 - 11 ( 11 )

Abstract:


Background: Food and herbal extracts rich in Quercetin (QRT) are often self-medicated by diabetics and can potentially alter the pharmacokinetics (PK) of Metformin HCl (MET) and Canagliflozin (CNG) leading to food or herb-drug interactions and reduced therapeutic efficacy. However, the impact of these flavonoids on the pharmacokinetic behaviour of MET and CNG is mostly unknown.

Method: A simple one-step protein precipitation method was developed for the determination of MET and CNG from rat plasma. The mobile phase chosen was MeOH 65% and 35% water containing 0.1% formic acid at a flow rate of 1mL/min.

Results: The retention time of MET, internal standard (Valsartan) and CNG was 1.83, 6.2 and 8.2 min, respectively. The method was found to be linear in the range of 200 - 8000 ng/mL for CNG and 100 = 4000 ng/ml for MET. Precision and accuracy of the method were below 20% at LLOQ and below 15% for LQC, MQC, and HQC.

Conclusion: The method was successfully applied for the determination of PK of MET and CNG by using 100 ┬ÁL of rat plasma. QRT co-administration affects the PK parameters of MET and CNG. This alteration in PK parameters might be of significant use for clinicians and patients.

Keywords:

Pharmacokinetics, validation, Quercetin, Canagliflozin, Metformin HCl, LC-MS/MS.

Affiliation:

SVKM`s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra, SVKM`s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra, SVKM`s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra, SVKM`s, NMIMS Deemed to be University, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, Mumbai, Maharashtra



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