Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC

A simple, rapid and sensitive RP-HPLC has been developed and validated for the simultaneous estimation of anti-diabetic drugs nateglinide (NAT) and pioglitazone (PIO), at a selected wavelength of 210 nm. The method provided linear responses within the concentration range which varies from 50 to 250...

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Main Authors: Sriparni Das, Suddhasattya Dey, Shahreja Parvej, Tapan Dutta, Anjan De, Chanchal Koley, Padmacharan Behra, Anjan Mondal, Sudip Pratihar, Saptarshy Sarkar, Arijit Mondal, Aliviya Das, Bishal Banerjee
Format: Article
Language:English
Published: University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association 2025-12-01
Series:Makedonsko Farmacevtski Bilten
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Online Access:http://bulletin.mfd.org.mk/volumes/Volume%2071_2/71_2_008.pdf
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Summary:A simple, rapid and sensitive RP-HPLC has been developed and validated for the simultaneous estimation of anti-diabetic drugs nateglinide (NAT) and pioglitazone (PIO), at a selected wavelength of 210 nm. The method provided linear responses within the concentration range which varies from 50 to 250 µg/mL for both NAT and PIO with LOD values of 0.18 µg/mL and 0.22 µg/mL for NAT and PIO, respectively, and the LOQ value of 0.57 µg/mL & 0.63 µg/mL, respectively. Mean percent recovery varied between 100.06 and 100.31% and mean RSD of 0.08% (repeatability) and 0.26% (intermediate precision). Other characteristics, such as robustness, system suitability and specificity, were also verified for the approach. According to the degradation investigation, NAT and PIO exhibited slight degradation under acid hydrolysis and were stable under oxidative and photocatalytic degradation. PIO remained stable in basic condition, while NAT was degraded by 15.36%. The approach that has been proposed holds great potential for routine quality control analysis involving the qualitative and quantitative determination of NAT and PIO in various pharmaceutical formulations.
ISSN:1409-8695
1857-8969