Spectrophotometric assay of pioglitazone hydrochloride using permanganate in acidic and basic media

Abstract: Pioglitazone hydrochloride (PGH) is an oral anti-hyperglycemic agent used in the treatment of type-2 diabetes mellitus. Potassium permanganate was found to oxidize PGH both in acidic and basic conditions, based on which two simple and sensitive methods were developed for its determination in bulk sample and tablets, and validated. In the first method (indirect method), PGH was reacted with a measured excess of standard permanganate in H₂SO₄ medium, and the residual oxidant was determined by measuring its absorbance at 550 nm. The second method (Direct method) entails treating PGH with permanganate in NaOH medium, followed by the measurement of the resulting bluish-green manganite at 610 nm. Experimental variables affecting the reactions were studied and optimized. Under optimum conditions, linear relationships with good correlation coefficients were found between absorbance and concentration in the ranges, 1.25 – 25 µg mL^-1 (Indirect method) and 1-12 µg mL^-1 (Direct method) with respective molar absorptivity values of 1.10 × 10⁴ and 2.77 × 10⁴ l mol^-1 cm^-1. The limits of detection (LOD) and quantification (LOQ) were 0.36 and 1.08 (Indirect method) and 0.23 and 0.69 µg mL^-1 (Direct method). Intra-day and inter-day precisions were satisfactory, with %RSD values of ≤2.11, and the respective accuracies were excellent with %RE values of ≤2. The methods were also validated for robustness, ruggedness and selectivity. The methods were applied to the determination of PGH in its tablets with good accuracy and precision, and no interference from the tablet additives was encountered. The results were also compared with those obtained by a reference method.

How to cite this paper

 Basavaiah, K & Rajendraprasad, N. (2018). Spectrophotometric assay of pioglitazone hydrochloride using permanganate in acidic and basic media.Current Chemistry Letters, 7(2), 45-56.

Refrences

1. Neil J.O. (2001). The Merck Index, Merck Research Laboratories. 13th Ed., Martindale, Merck.
2. Scheen A.J. (2012). Outcomes and lessons from the PROactive study. Diabet. Res. Clin. Prac., 98, 175–186.
3. Pfützner A., Forst T. (2006). Pioglitazone: an antidiabetic drug with the potency to reduce cardiovascular mortality. Expert Opin Pharmacother. 7, 463-476.
4. Satheeshkumar N., Shantikumar S., Srinivas R. (2014). Pioglitazone: A Review of Analytical Methods. J. Pharm. Anal., 4, 295-302.
5. Mahadik P.S., Senthilkumar G.P. (2012). Method development & validation of pioglitazone in bulk and pharmaceutical dosage forms by using spectrophotometric method. Asian J. Biochem. Pharm. Res., 2, 159-165.
6. Mohd S., Kulkarni A.P., Zaheer Z., Dehghan M.H. (2012). Spectroscopic estimation of pioglitazone hydrochloride. Int. J. Pharm. Frontier Res., 2, 87-94.
7. Shakya P., Singh K. (2010). Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by UV spectrophotometric method. Int. J. Pharm. Sci. Res., 1, 153-157.
8. Ali M.Y., Swamy P.V. , Borgaonkar P. (2008). UV-spectrophotometric determination of pioglitazone in pharmaceutical dosage forms. Int. J. Chem. Sci., 6, 2062-2065.
9. Patil S., Dwivedi S., Bagade S. (2011). Development of spectrophotometric method for the estimation of pioglitazone HCl from two different marketed brands. Am. J. PharmTech Res.,1, 264-275.
10. Sunitha P.G., Deattu N., Umarani N. (2010). Spectrophotometric method for the determination of Pioglitazone in pharmaceutical dosage forms. Der Pharm. Chem., 2, 202-204.
11. Bodar J.D., Kumar S., Yadav Y.C., Seth A.K., Deshmukh G.J., Sen A.K., Shah A. (2011). Development of the spectrophotometric method for the simultaneous estimation of piogliazone and metformin. Pharma Sci. Monitor An Int. J. Pharm. Sci., 2: 236-243.
12. Kumar S.S., Krishnaveni Y., Ramesh G. (2012). Simultaneous estimation of sitagliptin and pioglitazone by UV-spectroscopic method and study of interference of various excipients on this combination of drugs. Int. J. Curr. Pharm. Res., 4, 113-116.
13. Adhikari L., Jagadev S., Sahoo S., Murthy P.N., Mishra U.S. (2012). Devlopement and validation of UV–visible spectrophotometric method for simultaneous determination of pioglitazone HCl, metformin HCl and glipizide in its bulk and pharmaceutical dosage form (tablet). Int. J. ChemTech Res., 4, 625-630.
14. Deepa P., Laxmanbhai P., Madhabhai P., Advaita P.B. (2011). Simultaneous estimation of glimepiride, pioglitazone HCl and metformin HCl by derivative spectrophotometry method. Int. Res. J. Pharm.,2, 111-114.
15. Dhole S.M., Khedekar P.B., Amnerkar N.D. (2013). UV spectrophotometric absorption correction method for the simultaneous estimation of pioglitazone HCl, metformin HCl and glibenclamide in multicomponent formulation. Int. J. Anal. Bioanal. Chem., 3, 18-22.
16. Game M.D. (2011). First order derivative spectrophotometric method for simultaneous estimation of glimepiride and pioglitazone HCl in combined dosage form. J. Pharm. Res., 4, 4301-4310.
17. Havele O.S., Havele S.S. (2011). Simultaneous determination of atorvastatin calcium and pioglitazone hydrochloride in its multicomponent dosage forms by UV spectrophotometry. Int. J. Pharm. Sci. Res., 1, 75-79.
18. Kishore L., Kaur N. (2011). Estimation of pioglitazone and glimipride in its pharmaceutical dosage form by spectrophotometric methods. Der Pharm. Lett., 3, 276-284.
19. Pallavi P.M., Sonali R.D., Praveen C.D. (2012). Development and validation of UV derivative spectrophotometric methods for the determination of glimepiride, metformin HCl and pioglitazone HCl in bulk and marketed formulation. J. Pharm. Sci. Innov., 1, 58-62.
20. Rathod S.D., Patil P.M., Jadhav S.B., Chaudhary P.D. (2012). UV-spectrophotometric simultaneous determination of metformin HCl and pioglitazone HCl in combined dosage form. Asian J. Pharm. Anal., 2, 5-9.
21. Singhvi I., Mehta K., Kapadiya N. (2011). Analytical method development and validation for the simultaneous estimation of pioglitazone and glimepiride in tablet dosage form by multiwavelength spectroscopy. J. Appl. Pharm. Sci., 1, 159-161.
22. Sujana K., Abbulu K., Souri O.B., Archana B., Sindu M., Rani G.S. (2011). Difference spectrophotometric methods for pioglitazone HCl and metformin HCl. J. Pharm. Sci. Res., 3, 1122-1126.
23. Sujana K., Rani G.S., Prasad M.B., Reddy M.S. (2010). Simultaneous estimation of pioglitazone HCl and metformin HCl using UV spectroscopic method. J. Biomed. Sci. Res., 2, 110-115.
24. Faridbod F., Ganjali M.R., Esfahani E.N., Larijani B., Riahi S., Norouzi P. (2010). Potentiometric sensor for quantitative analysis of pioglitazone hydrochloride in tablets based on theoretical studies. Int. J. Electrochem. Sci., 5, 880-894.
25. Mostafa G.A., Al-Majed A. (2008). Characteristics of new composite-and classical potentiometric sensors for the determination of pioglitazone in some pharmaceutical formulations. J. Pharm. Biomed. Anal., 48, 57-61.
26. El-Ghobashy M.R., Yehia A.M., Mostafa A.A. (2009). Application of membrane-selective electrodes for the determination of pioglitazone HCl in the presence of its acid degradant or metformin HCl in tablets and plasma. Anal. Lett., 42, 123-140.
27. Badawy W.A., El-Ries M.A., Mahdi I.M. (2009). Carbon paste-and PVC membrane electrodes as sensitive sensors for the determination of antidiabetic drugs for type 2 diabetic patients. Anal. Sci., 25, 1431-1436.
28. Al-Arfaj N.A., Al-Abdulkareem E.A., Aly F.A. (2009). Flow-injection chemiluminometric determination of pioglitazone HCl by its sensitizing effect on the cerium-sulfite reaction. Anal. Sci., 25, 401-406.
29. Jiladia M.A., Pandya S.S., Jiladia A.G. (2010). Estimation of pioglitazone in bulk and tablet dosage forms by HPLC method. Int. J. Pharm. Sci., 2, 386-389.
30. Srinivasulu D., Sastry B.S., Omprakash G. (2010). Development and validation of new RP-HPLC method for determination of pioglitazone HCl in pharmaceutical dosage forms. Int. J. Chem. Res., 1, 18-20.
31. Saber A.M.R.L. (2008). Determination of pioglitazone hydrochloride in tablets by high-performance liquid chromatography. Pak. J. Anal. Environ. Chem., 9, 118-121.
32. Radhakrishna T., Rao D.S., Reddy G.O. (2002). Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. J. Pharm. Biomed. Anal., 29, 593-607.
33. Jedlicka A., Klimes J., Grafnetterova T. (2004). Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets. Pharmazie, 59, 178-182.
34. Madhukar A., Naresh K., Kumar C.N., Sandhya N., Prasanna P. (2011). Rapid and sensitive RP-HPLC analytical method development and validation of pioglitazone hydrochloride. Der. Pharm. Lett., 3, 128-132.
35. Sharma S., Sharma M.C., Chaturvedi S.C. (2010). Study of stressed degradation behavior of pioglitazone hydrochloride in bulk and pharmaceutical formulation by HPLC assay method. J. Optoelectronics and Biomed. Materials, 1, 17-24.
36. Rashmitha N., Hiriyanna S.G., Rao C.H.S., Reddy K.C.S., Kiran M.H., Sharma H.K., Mukkanti K. (2010). A validated stability indicating HPLC method for the determination of impurities in pioglitazone hydrochloride. Der. Pharm. Chem., 2, 426-432.
37. Reddy G.R.K.,Rao V.S.N. (2012). Development and validation of stability indicating assay method for pioglitazone drug substance by reverse phase HPLC. J. Global Trends Pharm. Sci., 3, 584-596.
38. Wanjari D.B., Gaikwad N.J. (2005). Stability indicating RP-HPLC method for determination of pioglitazone from tablets. Indian J. Pharm. Sci., 67, 256-258.
39. Sriram V., Sriram K., Angirekula J. (2012). Development and validation of stability indicating reverse phase HPLC method for the determination of impurities in pioglitazone hydrochloride. Int. J. Pharm. Biomed. Sci., 3, 89-96.
40. Narasimham L.Y.S., Barhate V.D. (2010). Development and validation of stability indicating UPLC method for the simultaneous determination of anti-diabetic drugs in pharmaceutical dosage forms. J. Pharm. Res., 3, 3081-3087.
41. Jiladia M.A., Pandya S.S.,Vidyasagar G. (2009). A simple and sensitive HPTLC method for estimation of pioglitazone inbulk and tablet dosage forms. Asian J. Res. Chem., 2, 207-209.
42. Singh S.C.D.D., Kushnoor A. (2011). Development and validation of a HPTLC method for estimation of pioglitazone in bulk and tablet dosage form. J. Pharm. Res., 4, 3919-3921.
43. Gumieniczek A., Hopkała H., Berecka A. (2005). Reversed‐phase thin‐layer chromatography of three new oral antidiabetics and densitometric determination of pioglitazone. J. Liq. Chromatogr. Rel. Technol., 27, 2057-2070.
44. Sharma M., Sharma S., Kohli D. (2010). HPTLC method development and validation for the estimation of atorvastatin calcium and pioglitazone HCl in pharmaceutical combined tablet dosage form. Ann. Biol. Res., 1, 124-129.
45. Anand D.P. (2010). HPTLC method for determination of telmesarton HCl with pioglitazone HCl in pharmaceutical dosage form. Int. J. Pharm. Res., 2, 185-190.
46. Kale D., Kakde R. (2011). Simultaneous determination of pioglitazone, metformin, and glimepiride in pharmaceutical preparations using HPTLC method. J. Planar Chromatogr. Mod. TLC, 24, 331-336.
47. Calixto L.A., Bonato P.S. (2013). Combination of hollow-fiber liquid-phase microextraction and capillary electrophoresis for pioglitazone and its main metabolites determination in rat liver microsomal fraction. Electrophoresis, 34, 862-869.
48. 48. Geffery G.H., Basset J., Mendham J., Denney R.C. (1978 and 1979), Longman Group UK Ltd., Vogel’s Textbook of Quantitative Chemical Analysis, 5th Edition, p. 369.
49. Emara S. (2004). Determination of methotrexate in pharmaceutical formulations by flow injection analysis exploiting the reaction with potassium permanganate. IL Farmaco, 59, 827-833.
50. Rahman N., Ahmad Y., Azmi S.N.H. (2004). Kinetic spectrophotometric method for the determination of norfloxacin in pharmaceutical formulations. Eur. J. Pharm. Biopharm., 57, 359-367.
51. Tammilehto S.A. (1980). Oxidation of chlorprothixene with potassium permanganate. J. Pharm. Pharmacol., 32, 524-524.
52. Murugesan A., Venkappayya D. (1983). New method for estimation of isoniazid. Curr. Sci., 52, 249-249.
53. Kucharski M., Sikorska-Tomicka H. (1982). Potentiometric and amperometric determination of methyl thiouracil with potassium permanganate. Chem. Anal. (Warsaw), 27, 491-496.
54. Stepnayuk S.N., Balagorazumnya N.V. (1989). Permanganometric determination of amidopyrine in dosage forms. Farmatsiya (Moscow), 38, 67-69.
55. Suganthi A., Shivakumar H.B., Vijaykumar S.C., Ravimathi P., Ravi T.K. (2006). Visible spectrophotometric determination of valdecoxib in tablet dosage forms. Indian J. Pharm. Sci., 68, 373-374.
56. Al-Tamrah S.A. (1999). Spectrophotometric determination of nicotine. Anal. Chim. Acta., 379, 75-80.
57. Abdellatef H.E. (2002). Kinetic spectrophotometric determination of tramadol hydrochloride in pharmaceutical formulation. J. Pharm. Biomed. Anal., 29, 835-842.
58. Reddy M.N., Reddy V.P.N., Reddy P.J.C., Murthy T.K., Srinivasa Rao Y. (2002). Spectrophotometric determination of cefuroxime sodium in pharmaceutical dosage forms. Antiseptic., 99, 88-89.
59. Al-Ghanman S.M., Belal F. (2001). - Spectrophotometric determination of diloxanide furoate in its dosage forms. IL Farmaco, 56, 677-681.
60. Sastry C.S.P., Vijaya R.T., Satyanarayana A. (1998). Spectrophotometric determination of pentazocine in pharmaceutical formulations. Indian. J. Pharm. Sci., 60, 55-58.
61. Vogel, A.I. (1961). A Text-book of Quantitative Inorganic Analysis, 7th Ed., The English Language Book Edition Society, London, p.280.
62. Mann, F.G., Sounders, B.C. (1974). In; New Impression 1974, 4th Ed., Longman, Cambridge, p.85.
63. International Conference on Hormonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Complementary Guideline on Methodology dated 06 November 1996, incorporated in November 2005, London. UK. http://www.ich.org/LOB/media/MEDIA417.pdf.
64. Vogel, A.I. (1961) A Text-book of Quantitative Inorganic Analysis. 3rd Ed., The English Language Book Edition Society, London, p.280.
65. Vogel (1961) Text Book of Quantitative Inorganic Analysis, Longmans, London, p. 243.