A Review of Analytical Methods for the Determination of Nateglinide in Pharmaceuticals and Biological Samples

Basavaiah, K.; Penmatsa, Vamsi Krishna

doi:10.1007/s11094-016-1386-1

Cited by 6 publications

(1 citation statement)

References 68 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…5 The synergistic action of both drugs is beneficial in patients who are nonresponsive to traditional monotherapy and its coadministration does not affect the pharmacokinetic behavior of the individual drug. 6 The published studies described simultaneous estimation of nateglinide and metformin hydrochloride by UV, 7,8 HPTLC, 9,10 micellar liquid chromatography, 11 and HPLC [12][13][14][15][16] in pharmaceutical dosage forms. For biostudies, UP-HPLC, 17 RP-HPLC, 18 and LC-MS 19 are currently available for individual estimation of both drugs in human plasma, 20 rabbit plasma, 21,22 and rat plasma.…”

Section: Introductionmentioning

confidence: 99%

Design of experiment‐based LC‐MS/MS method development for simultaneous estimation of nateglinide and metformin hydrochloride in rat plasma

et al. 2021

View full text Add to dashboard Cite

This research aims to develop and validate a bioanalytical method for simultaneous estimation of an antidiabetic combination using LC-MS/MS in rat plasma. Nateglinide and metformin hydrochloride are commonly used combination for clinical management of Type 2 diabetes. Hence, simultaneous determination in plasma is essential for the rapid analysis of samples from the pharmacokinetic studies. Statistical optimization was carried out for liquid chromatography (LC) parameters and mass spectroscopic (MS) parameters by design of experiment (DoE) (Design Expert Version 11, Stat Ease Inc., USA) approach. A 3 3 full factorial design was used for optimization of LC parameters; %methanol, %formic acid, and flow rate were selected as independent variables, whereas peak area and tailing factor were considered as dependent variables for both drugs. Box-Behnken design was used to optimize MS parameters including drying gas flow rate, nebulizing gas flow rate, DL temperature, heat block temperature, and positive voltage as independent factors, and responses selected were [M + H] + intensity of nateglinide and metformin hydrochloride. The [M + H] + intensity of the optimized method for nateglinide and metformin hydrochloride were 2,462,838 and 11,873,826, respectively. The model was found significant for optimizing LC and MS parameters with p < 0.05 for both nateglinide and metformin hydrochloride. The optimized method was validated as per the ICH-M10 guideline, which was accurate, precise, and selective. The method was cost-effective and capable of quantitating concentrations in picogram levels for nateglinide and metformin hydrochloride simultaneously.

show abstract