HPLC-UV method for simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone in formulations and in human serum

doi:10.5246/jcps.2018.04.028

摘要/Abstract

摘要：

In this study, we reported and validated a novel and sensitive reversed-phase liquid chromatographic method for the simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone. Separation was performed at 230 nm using a mobile phase consisting of methanol–water (90:10, v/v) with a flow rate of 1 mL/min. pH was adjusted to 3.5 with phosphoric acid. The concentration-response relationship was found linear over a concentration range of 5–25 μg/mL for all of the analytes tested. The limits of detection and quantification were 0.83 and 2.78 for irbesartan, 0.30 and 1.01 for candesartan, 1.11 and 3.93 for gliquidone, and 0.41 and 1.41 μg/mL for pioglitazone, respectively. Described method permitted the successful determination of these drugs in human serum. The developed method was simple, rapid, and it did not require extensive sample purification.

关键词: Candesartan, Gliquidone, Irbesartan, Pioglitazone, RP-HPLC, Method development

Abstract:

Key words: Candesartan, Gliquidone, Irbesartan, Pioglitazone, RP-HPLC, Method development

中图分类号:

R917

Supporting:

Agha Zeeshan Mirza. HPLC-UV method for simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone in formulations and in human serum[J]. 中国药学(英文版), 2018, 27(4): 273-280.

Agha Zeeshan Mirza. HPLC-UV method for simultaneous determination of irbesartan, candesartan, gliquidone and pioglitazone in formulations and in human serum[J]. Journal of Chinese Pharmaceutical Sciences, 2018, 27(4): 273-280.

参考文献

[1] Danaei, G.; Finucane, M.M.; Lu, Y.; Singh, G.M.; Cowan, M.J.; Paciorek, C.J.; Lin, J.K.; Farzadfar, F.; Khang, Y.H.; Stevens, G.A.; Rao, M.; Ali, M.K.; Riley, L.M.; Robinson, C.A.; Ezzati, M. Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose), National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants. Lancet. 2011, 378, 31-40.

[2] Mathers, C.D.; Loncar, D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006, 3, e442.

[3] American Diabetes Association, Treatment of hypertension in Adults with diabetes. Diabetes Care. 2003, 26, s80-82.

[4] Nelson, P.K. Slowing progression along the renal disease continuum. J. Am Osteopath. Assoc. 2005, 105, 207-215.

[5] The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Arch Intern. Med. 1997, 157, 2413-2446.

[6] Claudio, B.; Arrigo, F.G. The role of irbesartan in the treatment of patients with hypertension, A comprehensive and practical review. High Blood Press CardiovascPrev. 2012, 19, 19-31.

[7] The Merck Index, 14th ed., Whitehouse Station, NJ: Merck Research Laboratories Division of Merck and Co., Inc.; 2006, 1742.

[8] Lorenzo, G.; Agostino, V.; Armando, M.; Stefano, T.; Antonio, S. Effect of the angiotensin ii type 1 receptor blocker candesartan on endothelial function in patients with essential hypertension. Hypertension. 2000, 35, 501-506.

[9] Malaisse, W.J. Gliquidone contributes to improvement of type 2 diabetes mellitus management: a review of pharmacokinetic and clinical trial data. Drugs. R.D. 2006, 7, 331-337.

[10] Lee, K.W.; Ku, Y.H.; Kim, M.; Ahn, B.Y.; Chung, S.S.; Park, K.S. Effects of Sulfonylureas on peroxisome proliferator-activated receptor γ activity and on glucose uptake by thiazolidinediones. Diabetes Metab. J. 2011, 35, 340-347.

[11] Qayyum, R.; Schulman, P. Cardiovascular effects of the thiazolidinediones. Diabetes Metab. Res. Rev. 2006, 22, 88-97.

[12] Erdmann, E.; Wilcox, R.G. Weighing up the cardiovascular benefits of thiazolidinedione therapy: the impact of increased risk of heart failure. Eur. Heart J. 2008, 29, 12-20.

[13] Shakya, A.K.; Al-Hiari, Y.M.; Alhamami, O.M. Liquid chromatographic determination of irbesartan in human plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2007, 848, 245-250.

[14] Nevin, E. Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by liquid chromatography. J. Chromatogr. B Analyt Technol Biomed. Life Sci. 2003, 784, 195-201.

[15] González, L.; López, J.A.; Alonso, R.M.; Jiménez, R.M. Fast screening method for the determination of angiotensin II receptor antagonists in human plasma by high-performance liquid chromatography with fluorimetric detection. J. Chromatogr. A. 2002, 949, 49-60.

[16] Chang, S.Y.; Whigan, D.B.; Vachharajani, N.N.; Patel, R. High-performance liquid chromatographic assay for the quantitation of irbesartan (SR 47436/BMS-186295) in human plasma and urine. J. Chromatogr. B Biomed. Sci. Appl. 1997, 702, 149-155.

[17] Bkhaitan, M.M.; Mirza A.Z. Stability-indicating HPLC-DAD method for simultaneous determination of atorvastatin, irbesartan, and amlodipine in bulk and pharmaceutical preparations. Bull. Korean Chem. Society. 2015, 36, 2230-2237.

[18] Arayne, M.S.; Sultana, N.; Mirza, A.Z. Spectrophotometric method for quantitative determination of gliquidone in bulk drug, pharmaceutical formulations and human serum. Pak. J. Pharm. Sci. 2006, 19, 185-189.

[19] Arayne, M.S.; Sultana, N.; Mirza, A.Z.; Siddiqui, F.A. Validated RP-HPLC method for quantitation of gliquidone in pharmaceutical formulation and human serum. J. Chilean Chem. Society. 2010, 55, 156-158.

[20] Arayne, M.S.; Sultana, N.; Mirza, A.Z.; Shamshad, H. High-performance liquid chromatographic analysis of pioglitazone, gliquidone, rosuvastatin and simvastatin in formulations and human serum. Chin. J. Chem. 2010, 28, 1998-2002.

[21] Arayne, M.S.; Sultana, N.; Mirza, A.Z.; Siddiqui, F.A. Simultaneous determination of gliquidone, fexofenadine, buclizine and levocetirizine in dosage formulation and human serum by RP-HPLC. J. Chromatogr. Sci. 2010, 48, 382-385.

[22] Arayne, M.S.; Sultana, N.; Mirza, A.Z. Simultaneous determination of gliquidone, pioglitazone hydrochloride and verapamil in formulation and human serum by RP-HPLC. J. Chromatogr. Sci. 2011, 49, 114-117.

[23] Mirza, A.Z.; Arayne, M.S.; Sultana, N. RP-LC method for the simultaneous determination of gliquidone, pioglitazone hydrochloride and atorvastatin in formulations and human serum. J. AOAC Int. 2013, 96, 56-59.

[24] Mirza, A.Z.; Arayne, M.S.; Sultana, N. Method Development and Validation of Amlodipine, Gliquidone and Pioglitazone: Application in the Analysis of Human Serum. Anal. Chem. Lett. 2014, 4, 302-312.

[25] Mirza, A.Z.; Arayne, M.S.; Sultana, N. HPLC method development, validation and its application to investigate in vitro effect of pioglitazone on the availability of H1 receptor antagonists. J. Assoc. Arab Univ. Basic Appl. Sci. 2017, 22, 70-75.

[26] Pinaki, S.; Amlan, KS.; Uttam, B.; Bappaditya, C.; Bikash, R.; Uday, S.C.; Tapan, K.P. Development and validation of an LC-ESI-MS/MS method for simultaneous quantitation of olmesartan and pioglitazone in rat plasma and its pharmacokinetic application. Biomed. Chromatogr. 2010, 24, 1342-1349.

[27] Chinna, R.P.; Ramesh, G.; Shravan, K.Y.; Vamshi, V.Y.; Madhusudan, R.Y. Development of a high-performance liquid chromatography method for simultaneous determination of pioglitazone and felodipine in pig serum: application to pharmacokinetic study. Biomed. Chromatogr. 2011, 25, 952-958.

[28] Siddiqui, F.A.; Sher, N.; Zubair, A.; Shamshad, H.; Shafi, N.; Mirza, A.Z. Analysis of metformin, glimepiride and pioglitazone in human serum and its application to pharmacokinetics. Anal. Methods. 2013, 5, 5096-5104.

[29] Sultana, N.; Naveed, S.; Arayne, M.S. An Ultra-Sensitive and Selective LC-UV Method for the Simultaneous Determination of Metformin, Pioglitazone, Glibenclamide and Glimepride in API, Pharmaceutical Formulations and Human Serum. J. Anal. Bioanal. Tech. 2013, 5, 1.

[30] ICH, Topic Q2(R1), Validation of Analytical Procedures: Methodology, 2005.
[31] Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001.