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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author 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
author_facet 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
author_sort Sriparni Das
collection DOAJ
description 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.
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publishDate 2025-12-01
publisher University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
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spelling doaj-art-a6300cd4e0954f72b34478c70436aaf72025-08-20T03:13:27ZengUniversity Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical AssociationMakedonsko Farmacevtski Bilten1409-86951857-89692025-12-01712758510.33320/maced.pharm.bull.2025.71.02.008Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLCSriparni Das0Suddhasattya Dey1Shahreja Parvej2Tapan Dutta3Anjan De4Chanchal Koley5 Padmacharan Behra6Anjan Mondal7Sudip Pratihar8Saptarshy Sarkar9Arijit Mondal10Aliviya Das11Bishal Banerjee12Department of Pharmacy, BCDA College of Pharmacy and Technology, Campus-2, Udairajpur, Madhyamgram, Kolkata-700129, West Bengal, IndiaDepartment of Pharmacy, IQ City Institute of Pharmaceutical Sciences, Durgapur-713206, West Bengal, IndiaDepartment of Pharmacy, Dr. B. C. Roy College of Pharmacy & Allied Sciences, Durgapur -713206, West Bengal, IndiaCaplet India Pvt. Ltd., P-937, Lake Town, Ground Floor, Block-A, Kolkata Warangal -700089, West Bengal, IndiaDepartment of Pharmacy, Dr. B. C. Roy College of Pharmacy & Allied Sciences, Durgapur -713206, West Bengal, IndiaDepartment of Pharmacy, Bengal College of Pharmaceutical Technology College, Dubrajpur-731123, West Bengal, IndiaDepartment of Pharmacy, Bengal College of Pharmaceutical Technology College, Dubrajpur-731123, West Bengal, IndiaDepartment of Pharmacy, IQ City Institute of Pharmaceutical Sciences, Durgapur-713206, West Bengal, IndiaDepartment of Pharmacy, IQ City Institute of Pharmaceutical Sciences, Durgapur-713206, West Bengal, IndiaDepartment of Pharmacy, IQ City Institute of Pharmaceutical Sciences, Durgapur-713206, West Bengal, IndiaDepartment of Pharmacy, IQ City Institute of Pharmaceutical Sciences, Durgapur-713206, West Bengal, IndiaDepartment of Pharmaceutical Chemistry, Calcutta Institute of Pharmaceutical Technology and Allied Health Sciences, Uluberia-711316, West Bengal, IndiaDepartment of Pharmacy, IQ City Institute of Pharmaceutical Sciences, Durgapur-713206, West Bengal, IndiaA 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. http://bulletin.mfd.org.mk/volumes/Volume%2071_2/71_2_008.pdfnateglinidepiogliatazonehplcuv detection
spellingShingle 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
Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC
Makedonsko Farmacevtski Bilten
nateglinide
piogliatazone
hplc
uv detection
title Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC
title_full Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC
title_fullStr Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC
title_full_unstemmed Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC
title_short Simultaneous stability-indicating analysis of nateglinide and pioglitazone using RP-HPLC
title_sort simultaneous stability indicating analysis of nateglinide and pioglitazone using rp hplc
topic nateglinide
piogliatazone
hplc
uv detection
url http://bulletin.mfd.org.mk/volumes/Volume%2071_2/71_2_008.pdf
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