Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms

Sinem Bilgiç Karaağaç; Dilek Bilgiç Alkaya; Serap Ayaz Seyhan; Buşra Nagihan Öztürk

Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms

Abstract

The present work reports an ultra-performance liquid chromatography (RP-UPLC) method for the quantitative determination of pioglitazone HCl (PGZ) in pharmaceutical dosage form. The chromatographic separation was performed on C18, BEH (50 mm x 2.1 mm, 1.7 μm) column using isocratic elution. The optimized mobile phase consists of phosphate buffer (pH:6) as a solvent-A and 55:45 v/v mixture of acetonitrile as solvent-B. Flow rate was 0.4 ml/min with UV detection at (λmax) 225 nm and the injection volume was set at 2 μL with retention time 1 min. The developed RP-UPLC method was validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, accuracy, linearity.

Keywords

References

[1] Ayvaz G, Kan E. Oral antidiabetic drugs treating type 2 diabetes mellitus treating type 2 diabetes mellitus. Mised. 2010; 23-24: 8-13.
[2] Aksoy DY, Georgia A. New hope in treating type 2 diabetes: Thiazolidinediones. Hacettepe Journal of Medicine. 2004; 35: 123-126.
[3] National Center for Biotechnology Information (2023). PubChem Compound Summary for CID 4829, Pioglitazone. Retrieved May 11, 2023 from https://pubchem.ncbi.nlm.nih.gov/compound/Pioglitazone.
[4] Satheeshkumar N, Shantikumar S, Srinivas R. Pioglitazone: A review of analytical methods. JPA. 2014; 4(5): 295-302. https://doi.org/10.1016/j.jpha.2014.02.002
[5] Pavalli PM, Rathod SD, Chaudhar PD. Development and validation of UV derivative spectrophotometric methods for the determination of glimepiride, metformin HCl and pioglitazone in bulk and marketed formulation. J Pharm Sci Innov. 2012; 1(3):58-62.
[6] Naveed ZA, Tasleem M. Assay of Pioglitazone HCL by using UV visible spectrophotometer. Br J Res. 2015; 2: 24.
[7] Shakya P, Kuldeep S. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by UV spectrophotometric method. Int J Pharm Sci Res. 2010; 1.11: 153. http://doi.org/10.13040/IJPSR.09758232.1(11).153-57
[8] Adukondalu D, Malathy PS, Venkateshwar J, Madhusudan Y. Development and validation of HPLC method for dedection of Pioglitazone Hydrochloride in dosage forms. Int J Pharm Bio Sci. 2011; 4: 474-478.

[9] Sayed S, Thomas A, Kotapali L. RP-HPLC method development for determination of pioglitazone hydrochloride from tablets. J Pharm Res. 2009; 2(9): 1479-1480.
[10] Jedlička A, Klimeš J, Grafnetterova T. Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets. Pharmazie. 2004; 59.3: 178-182.
[11] Saber AL. Determination of Pioglitazone Hydrochloride in tablets by High-Performance Liquid Chromatography. Pak J Anal Environ Chem Package. 2008; 9(2): 118-121.
[12] Srinivasulu D, Sastry BS, and Omprakash G. Development and validation of new RPHPLC method for determination of pioglitazone HCl in pharmaceutical dosage forms. Int J of Chem Res. 2010; 18-20.
[13] Shaik SB, Joshi K, Usha M, Bindhu T, Ramya T. Analytical method development and validation of pioglitazone hydrochloride by RP-HPLC. J Chem and Pharm Res. 2014; 6(6): 16-21.
[14] Rashmithaa N, Hiriyanna SG, Sreenivasa Rao CH. A validated stability indicating HPLC method for the determination of impurities in pioglitazone hydrochloride. Der Pharm Chem. 2010; 2: 426-433.
[15] Meenaxi MM, Nikhil SG, Utkarsh S, Poonam S. RP-HPLC method development and validation for Pioglitazone in bulk and marketed formulation. Der Pharma Chemica. 2021; 13(6): 6-15.
[16] Ashour S, Amir AS, and Manar K. Development and validation of stability indicating HPLC method for quality control of pioglitazone hydrochloride. Can Chem Trans. 2015; 3.1: 1-11. . https://doi.org/10.13179/03.01.0151
[17] Jain D, Jain S, Jain D, Amine M. Simultaneous estimation of Metformin Hydrochloride, Pioglitazone Hydrochloride, and Glimepiride by RP-HPLC in tablet formulation. J Chromatogr Sci. 2008; 46(6): 501-504. https://doi.org/10.1093/chromsci/46.6.501
[18] Lakshmi KS, Rajesh T, Sharma S. Simultaneous determination of Metformin and Pioglitazone by Reversed Phase HPLC in pharmaceutical dosage form. Int J Pharm Pharm Sci. 2009;1: 162-165.
[19] Sultana N, Saeed AM, Shafi N, Siddiqui FA, Hussain A. Development and validation of new assay method for the simultaneous analysis of Diltiazem. J Chromatogr Sci. 2011; 49(1): 774–779https://doi.org/10.1093/chrsci/49.10.774
[20] Lakshmi KS, Rajesh T. Development and validation of RP-HPLC method for simultaneous determination of Glipizide, Rosiglitazone, Pioglitazone, Glibenclamide and Glimepiride in pharmaceutical dosage forms and human plasma. J Iranian Chem Soc. 2011; 8(1): 31-37. https://doi.org/10.1007/BF03246199
[21] Kant R, Bodla RB, Kapoor G, Bhutani R. Optimization of a single HPLC-PDA method for quantifying Metformin, Gliclazide, Pioglitazone, Dapagliflozin, Empagliflozin, Saxagliptin, Linagliptin and Teneligliptin. Using Central Composite Design. Bioorg Chem. 2019; 91: 1-12. https://doi.org/10.1016/j.bioorg.2019.103111
[22] Wang L, Wang J, Lin C, Wang F, Li X, Liu W. Simultaneous quantification of Pioglitazone and Omarigliptin in rat plasma by UHPLC-MS/MS and its application to pharmacokinetic study after coadministration of the two drugs. Hindawi J Anal Methods Chem. 2021: 1-9. https://doi.org/10.1155/2021/6693366
[23] Fachi MM, Cerqueira LB, Leonart LP, Francisco TM, Pontarolo R. simultaneous quantification of antidiabetic agents in human plasma by a UPLC–QTOF-MS method. PLoS One. 2016; 11(12) : 0167107. https://doi.org/10.1371/journal.pone.0167107
[24] Cijo MX and Kanakapura B. Implementation of quality by design for the development and validation of Pioglitazone Hydrochloride by RP-UPLC with application to formulated form. International Scholarly Research Network ISRN Chromatogr. 2012; 1-11. https://doi.org/10.5402/2012/592849
[25] Abdel-Ghany MF, Ayad MF, Tadros MM. Enhanced LC–MS/MS analysis of Alogliptin and Pioglitazone in human plasma: applied to a preliminary pharmacokinetic study. J Chromatogr B. 2017; 1058: 93-101. https://doi.org/10.1016/j.jchromb.2017.04.043
[26] Li G, Zhao M, Zhao L. The drug interaction potential of Berberine Hydrochloride when Co- Administered with Simvastatin, Fenofibrate, Gemfibrozil, Metformin, Glimepiride, Nateglinide, Pioglitazone and Sitagliptin in Beagles. Arab J Chem. 2022; 15: 103562. https://doi.org/10.1016/j.arabjc.2021.103562
[27] ICH Q2 (R1), Validation of analytical procedures, in: Proceedings of the International Conference on Harmonisation, 2005.
[28] Dhani R, Kumar H, Guptha HKDR, Rajamanickam D. Development of stability indicating method for the simultaneous estimation of alogliptin and pioglitazone in bulk and tablet dosage form by reversed-phase ultra-performance liquid chromatography method. J Appl Pharm Sci. 2019; 9(12): 051-056. [https://doi.org/10.7324//JAPS.2019.91208

Details

Primary Language

English

Subjects

Pharmaceutical Delivery Technologies

Journal Section

Research Article

Authors

Sinem Bilgiç Karaağaç
0000-0002-5706-9346
Türkiye

Dilek Bilgiç Alkaya ^*
0000-0002-7837-0250
Türkiye

Serap Ayaz Seyhan
0000-0001-5908-2766
Türkiye

Buşra Nagihan Öztürk
0000-0001-6062-039X
Türkiye

Publication Date

June 28, 2025

Submission Date

April 13, 2023

Acceptance Date

May 22, 2023

Published in Issue

Year 2024 Volume: 28 Number: 1

IZ

https://izlik.org/JA82EZ47TU

Cite

RIS / Bibtex

APA

Bilgiç Karaağaç, S., Bilgiç Alkaya, D., Ayaz Seyhan, S., & Öztürk, B. N. (2025). Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms. Journal of Research in Pharmacy, 28(1), 385-395. https://izlik.org/JA82EZ47TU

AMA

1.Bilgiç Karaağaç S, Bilgiç Alkaya D, Ayaz Seyhan S, Öztürk BN. Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms. J. Res. Pharm. 2025;28(1):385-395. https://izlik.org/JA82EZ47TU

Chicago

Bilgiç Karaağaç, Sinem, Dilek Bilgiç Alkaya, Serap Ayaz Seyhan, and Buşra Nagihan Öztürk. 2025. “Validation of an UPLC Method for the Determination of Pioglitazone Hydrochloride Active Substance in Pharmaceutical Dosage Forms”. Journal of Research in Pharmacy 28 (1): 385-95. https://izlik.org/JA82EZ47TU.

EndNote

Bilgiç Karaağaç S, Bilgiç Alkaya D, Ayaz Seyhan S, Öztürk BN (June 1, 2025) Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms. Journal of Research in Pharmacy 28 1 385–395.

IEEE

[1]S. Bilgiç Karaağaç, D. Bilgiç Alkaya, S. Ayaz Seyhan, and B. N. Öztürk, “Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms”, J. Res. Pharm., vol. 28, no. 1, pp. 385–395, June 2025, [Online]. Available: https://izlik.org/JA82EZ47TU

ISNAD

Bilgiç Karaağaç, Sinem - Bilgiç Alkaya, Dilek - Ayaz Seyhan, Serap - Öztürk, Buşra Nagihan. “Validation of an UPLC Method for the Determination of Pioglitazone Hydrochloride Active Substance in Pharmaceutical Dosage Forms”. Journal of Research in Pharmacy 28/1 (June 1, 2025): 385-395. https://izlik.org/JA82EZ47TU.

JAMA

1.Bilgiç Karaağaç S, Bilgiç Alkaya D, Ayaz Seyhan S, Öztürk BN. Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms. J. Res. Pharm. 2025;28:385–395.

MLA

Bilgiç Karaağaç, Sinem, et al. “Validation of an UPLC Method for the Determination of Pioglitazone Hydrochloride Active Substance in Pharmaceutical Dosage Forms”. Journal of Research in Pharmacy, vol. 28, no. 1, June 2025, pp. 385-9, https://izlik.org/JA82EZ47TU.

Vancouver

1.Sinem Bilgiç Karaağaç, Dilek Bilgiç Alkaya, Serap Ayaz Seyhan, Buşra Nagihan Öztürk. Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms. J. Res. Pharm. [Internet]. 2025 Jun. 1;28(1):385-9. Available from: https://izlik.org/JA82EZ47TU