DEVELOPMENT AND VALIDATION OF NOVEL SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE AND METFORMIN IN BULK AND FIXED DOSAGE FORMS BY AREA UNDER CURVE AND DUAL WAVELENGTH MODE
Objective: Two simple, accurate and reproducible spectrophotometric methods have been developed and validated for simultaneous estimation of metformin (MET) and pioglitazone (PIO) in bulk and tablet dosage forms.
Methods: (1) Area under curve method (Area calculation): The proposed area under the curve method involves measurement of area at selected wavelength ranges. Two wavelength ranges were selected 228-238 nm and 265-275 nm for estimation of MET and PIO respectively. (2) Dual wavelength method: In the dual-wavelength method, two wavelengths were selected for each drug in a way so that the difference in absorbance is zero for another drug. PIO shows equal absorbance at 235 and 266 nm, where the difference in absorbance was measured for determination of MET. Similarly, the difference in absorbance at 216 and 241.5 nm was measured for determination of MET.
Results: Linearity range for MET and PIO is 2-10 Î¼g/ml and 10-50 Î¼g/ml at respective selected wavelengths. Accuracy and precision studies were carried out, and results were satisfactory. The proposed methods have been validated as per ICH guidelines and successfully applied to the estimation of MET and PIO in their combined tablet dosage form.
Conclusion: The developed methods are simple, precise, rugged and economical. The utility of the methods has been demonstrated by analysis of commercially available formulations.
Keywords: Metformin, Pioglitazone, Area under curve method, Dual wavelength method
2. Fujimoto WY. The importance of insulin resistance in the pathogenesis of type 2 diabetes mellitus. Am J Med 2000;108:9-14.
3. Inzucchi SE. Oral antihyperglycemic therapy for type 2 diabetes. JAMA 2002;287:360-72.
4. Lebovitz HE. Oral antidiabetic agents. Med Clin North Am 2000;88:847-9.
5. Charpentier G, Fluery F, Kabir M, Kaur S, Halimit S. Improved glycemic control by the addition of glimepiride to metformin monotherapy in type 2 diabetic patients; diabetic UK. Diabetic Med 2001;18:828-34.
6. Van Gaal LF, De Leeuw IH. Rationale and options for combination therapy in the treatment of type II. Diabetologia 2000;46:44-50.
7. Reassner CA. Promising new approaches. Diabetes Obes Metab 1999;1:41-8.
8. Cox SL. Diabetes control and complications: the role of glycated haemoglobin, 25 y on. Diabetes Today 2004;40:633-43.
9. United States Pharmacopoeia, United States Pharmacopoeia Convention. Inc, Rockville, MD; 2011. p. 3933.
10. National Center for Biotechnology Information. PubChem Compound Database; CID=4829. Available from: https:// pubchem.ncbi.nlm.nih.gov/compound/4829[Last accessed on 01 Feb 2016].
11. United States Pharmacopoeia, United States Pharmacopoeia Convention. Inc, Rockville, MD; 2011. p. 3442.
12. National Center for Biotechnology Information. PubChem Compound Database; CID=4091. Available from: https:// pubchem.ncbi.nlm.nih.gov/compound/4091. [Last accessed on 25 Feb 2016].
13. K Sujana, G Swathi Rani, M Bhanu Prasad, M Saheethi Reddy. Simultaneous estimation of pioglitazone hydrochloride and metformin hydrochloride using UV spectroscopic method. J Biomed Sci Res 2010;2:110-5.
14. Omnia Ismaiel, Hisham Elrefay, Wafaa Hassan, Abdalla Shalaby. Development and validation of stabilityâ€“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.
15. Dipak Kale, Rajendra Kakde. Simultaneous determination of pioglitazone, metformin, and glimepiride in pharmaceutical preparations using HPTLC method. J Planar Chromatogr-Mod TLC 2014;24:331â€“6.
16. Dhanya B Sen, Sen AK, Aarti Zanwar, Balaraman R, Seth AK. Determination of alogliptin benzoate and Metformin hydrochloride in tablet dosage form by simultaneous equation and absorption ratio method. Int J Pharm Pharm Sci 2015;7:380-3.
17. Prasanthi Chengalva, Angala Parameswari S, Aruna G. Development and validation of RP-HPLC method for metformin hydrochloride and nateglinide in bulk and combined dosage form. Int J Pharm Pharm Sci 2016;8:267-71.
18. Mallikarjuna Rao N, Gowri Sankar 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.
19. Chinnalalaiah Runja, Ravi kumar P, Srinivasa Rao Avanapu. Stability indicating RP-HPLC method for simultaneous estimation of Alogliptin benzoate and metformin hydrochloride in tablet dosage form. Int J Pharm Pharm Sci 2016;8:116-20.
20. Ciddi Veeresham, Jillala Srivani, Balekari Umamahesh. Development and validation of stability indicating HPTLC method for simultaneous determination of Linagliptin and metformin. Int J Pharm Pharm Sci 2016;8:112-5.
21. James D Terish Bino, Kannappan, Sasi Jith, Suresh Kumar. Simultaneous estimation and method development for l-carnitine and metformin in human plasma using the liquid chromatography mass spectrometer. Asian J Pharm Clin Res 2015;8:185-91.
22. Rathod SD, Patil PM, Jadhav SB, Chaudhari PD. UV spectro-photometric simultaneous determination of metformin hydrochloride and pioglitazone hydrochloride in combined dosage form. Asian J Pharm Anal 2012;2:5-9.
23. Laxmi Goswami, Mukhopadhyay S, Durgapal S. Simultaneous estimation of metformin and pioglitazone by ultraviolet spectrophotometry. Indian J Pharm Sci 2010;72:508â€“10.
24. ICH, Q2 (R1), harmonized tripartite guideline, Validation of analytical procedures: text and methodology International Conference on Harmonization ICH, Geneva; 2005.