SENSITIVE DETERMINATION OF RELATED SUBSTANCES IN PIOGLITAZONE HYDROCHLORIDE BY HPLC
DOI:
https://doi.org/10.22159/ijap.2017v9i2.16828Keywords:
Pioglitazone hydrochloride, Related substances, HPLC, ValidationAbstract
Objective: An efficient, high performance liquid chromatographic method has been developed and validated for the quantification of related substances in pioglitazone hydrochloride drug substance.
Methods: This method includes the determination of three related substances in pioglitazone hydrochloride. The mobile phase A is 0.1% w/v triethylamine in water with pH 2.5 adjusted by dilute phosphoric acid. The mobile phase B is premixed and degassed mixtures of acetonitrile and methanol. The flow rate was 1 ml/min. The elution used was gradient mode. The HPLC column used for the analysis was symmetry C18 with a length of 250 mm, the internal diameter of 4.6 mm and particle size of 5.0 microns.
Results: The developed method was found to be linear with the range of 0.006-250% with a coefficient of correlation 0.99. The precision study revealed that the percentage relative standard deviation was within the acceptable limit. The limit of detection and limit of quantitation of the impurities was less than 0.002%and 0.006% with respect to pioglitazone hydrochloride test concentration of 2000 µg/ml respectively. This method has been validated as per ICH guidelines Q2 (R1).
Conclusion: A reliable, economical HPLC method was magnificently established for quantitative analysis of related substances of pioglitazone hydrochloride drug substance.
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References
Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, et al. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med 2006;355:2297-307.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf. [Last accessed on 20 Nov 2016]
Radhakrishna T, Rao DS, Reddy GO. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. J Pharm Biomed Anal 2002;29:593-607.
Reddy GRK, Rao VSN. Development and validation of stability indicating assay method for pioglitazone drug substance by reverse phase HPLC. J Global Trends Pharm Sci 2012;3:584-96.
Sharma S, Sharma MC, Chaturvedi SC. Study of stressed degradation behaviour of pioglitazone hydrochloride in bulk and pharmaceutical formulation by HPLC assay method. J Optoelectron Biomed Mater 2010;1:17-24.
Saber AMRL. Determination of pioglitazone hydrochloride in tablets by high-performance liquid chromatography. Pak J Anal Environ Chem 2008;9:118-21.
Jedlicka A, Klimes J, Grafnetterova T. Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets. Pharmazie 2004;59:178-82.
Wanjari DB, Gaikwad NJ. Stability indicating a RP-HPLC method for determination of pioglitazone from tablets. Indian J Pharm Sci 2005;67:256-8.
Sane RT, Menon SN, Inamdar S, Mote M, Gundi G. Simultaneous determination of pioglitazone and glimepiride by high-performance liquid chromatography. Chromatographia 2004;59:451-3.
Swapna J, Madhu C, Srivani S, Sumalatha M, Nehalatha Y, Anusha Y. Analytical method development and method validation for the simultaneous estimation of metformin hydrochloride and pioglitazone hydrochloride in tablet dosage form by RP-HPLC. Asian J Pharm Anal 2012;2:85-9.
Karthik A, Subramanian G, Rao CM, Bhat K, Ranjithkumar A, Musmade P, et al. Simultaneous determination of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form by RP-HPLC method. Pak J Pharm Sci 2008;21:421-5.
Jain D, Jain S, Maulik A. Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride and glimepiride by RP-HPLC in tablet formulation. J Chromatogr Sci 2008;46:501-4.
Sarat M, Krishna PM, Rambabu C. RP-HPLC method for estimation of saxagliptin and pioglitazone in tablets. Int Res J Pharm 2012;3:399-402.
Kalyankar TM, Badgujar MR, Kakde RB. Simultaneous determination of pioglitazone HCl and glimepiride by RP-HPLC in pharmaceutical dosage form. J Pharm Res 2010;3:3078-80.
Havaldar FH, Vairal DL. Simultaneous estimation of glimepiride, rosiglitazone and pioglitazone hydrochloride in the pharmaceutical dosage form. J Chem 2010;7:1326-33.
Shankar MB, Modi VD, Shah DA, Bhatt KK, Mehta RS, Patel BJ. Estimation of pioglitazone hydrochloride and metformin hydrochloride in tablets by derivative spectrophotometry and liquid chromatographic methods. J AOAC Int 2005;88:1167-72.
Nirupa G, Tirupathi UM. RP-HPLC analytical method development and validation for simultaneous estimation of three drugs: glimepiride, pioglitazone and metformin and its pharmaceutical dosage forms. J Chem 2013;2013:1-8.
Sakuntala MSV, Prasad SVUM, Devi SS, Yadav K, Reddy KS. A RP-HPLC method development and validation for the simultaneous estimation of glimepiride and pioglitazone HCl in tablet dosage forms. J Chem Pharm Res 2012;4:154-9.
Navaneethan G, Karunakaran K, Elango KP. Simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities in combination drug product by a validated stability-indicating RP-HPLC method. J Chil Chem Soc 2011;56:815-8.
Shweta H, Dhaneshwar S. Development and validation of a HPLC method for the determination of metformin HCl, gliclazide and pioglitazone hydrochloride in the multi-component formulation. Webmed Central Pharm Sci 2010;10:1-16.
Vinodkumar K, Sudhakar M, Padmanabhareddy Y, Swapna A, Rajanisekhar V. Method development and validation for simultaneous estimation of pioglitazone and glimepiride in tablet dosage form by RP-HPLC and UV-spectrophotometric method. J Curr Pharma Res 2011;2:404-10.
Premanand DC, Senthilkumar KL, Senthilkumar B, Saravanakumar M, Thirumurthy R. A new RP-HPLC method development and validation for simultaneous estimation of telmisartan and pioglitazone in pharmaceutical dosage form. Int J Chem Tech Res 2011;3:448-54.
Lakshmi KS, Rajesh T, Sharma S, Lakshmi S. Development and validation of liquid chromatographic and UV derivative spectrophotometric methods for the determination of metformin, pioglitazone and glimepiride in pharmaceutical formulations. Pharma Chem 2009;1:238-46.
Sharma MC, Sharma S, Kohli DV, Chaturvedi SC. Micellar liquid chromatographic analytical method development and validation of determination of atorvastatin calcium and pioglitazone in tablet dosage form. Pharma Chem 2010;2:273-80.
Madhukar A, Naresh K, Naveenkumar CH, Sandhya N, Prasanna P. Rapid and sensitive RP-HPLC analytical method development and validation of pioglitazone hydrochloride. Pharm Lett 2011;3:128-32.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. [Last accessed on 20 Nov 2016]
Rashmitha N, Hiriyanna SG, Sreenivasarao CH, Chandrasekhar reddy K, Harikiran M, Hemantkumarsharma, et al. A validated stability indicating HPLC method for the determination of impurities in pioglitazone hydrochloride. Pharma Chem 2010;2:426-33.
Balaji N, Sayeeda S. Ultra-high performance liquid chromatographic determination of genotoxic impurities in febuxostat drug substance and products. Asian J Pharm Clin Res 2017;10:324-30.
Hisham E, Omnia AI, Wafaa SH, Abdalla S. Development and validation of a stability-indicating HPLC-UV method for the determination of pioglitazone hydrochloride and metformin hydrochloride in bulk drug and combined dosage form. Asian J Pharm Clin Res 2013;6:116-20.
Balaji N, Sayeeda S. Trace level determination and quantification of potential genotoxic impurities in dasatinib drug substance by UHPLC/infinity LC. Int J Pharm Pharm Sci 2016;8:209-16.
Mallikarjuna RN, Gowrisankar D. RP-HPLC method for simultaneous estimation and stability indicating the study of metformin and linagliptin in pure and pharmaceutical dosage forms. Int J Pharm Pharm Sci 2015;7:191-7.
