METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUSESTIMATION OF ALOGLIPTIN AND PIOGLITAZONE IN COMBINED TABLET DOSAGE FORMS BY RP-HPLC
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Keywords
Alogliptin, Pioglitazone, Liquid Chromatography, Tablets, Assay
Abstract
A high performance liquid chromatographic method was developed to quantify alogliptin and pioglitazone simultaneously in bulk and combined tablet dosage form. The chromatographic analysis was done on a Zorbax C8 column (150 mm x 4.6 mm internal diameter, 5 μm particle size) with a mobile phase of 0.1 M ammonium acetate and methanol (50:50, v/v) at 1.0 mL/min. The effluents were monitored at 248 nm and the retention time of alogliptin and pioglitazone were 2.883 min and 4.329 min, respectively. Calibration curves were linear from 6.25-18.75 μg/mL for alogliptin and 11.25-33.75 μg/mL for pioglitazone. The LOD and LOQ values for alogliptin were 0.047 and 0.157 μg/mL, respectively corresponding values for pioglitazone were 0.085 and 0.284 μg/ mL, respectively. The precision for alogliptin and pioglitazone was in the range of 0.094-0.3 03 % and 0.072-0.239%, respectively, with corresponding accuracy of 99.450-99.692% and 100.184-100.422%. The developed and validated method was successfully applied for the simultaneous determination of alogliptin and pioglitazone in tablet formulation.
References
2. James WM, Editor. Pharmaceutical Analysis, Part B, International medical book distributors; New Delhi: 2001.
3. Frank AS, Editor. Handbook of instrumental techniques for analytical chemistry, Pearson education publishers; New Delhi: 2007.
4. John A, Editor. Chromatographic analysis of pharmaceutical. 2nded. Marcel Dekker; New York: 2006.
5. Kazakevich YV and Lo Brutto R, editors. HPLC for pharmaceutical scientists. John Wiley & Sons; New Jersey: 2007.
6. Neue UD. HPL C columns: theory, Technology, and practice. Wiley-VCH; New Jersey: 1997.
7. BeckettAH, Stenlake JB, Editors. Practical pharmaceutical chemistry, 4thed. Vol. I& II CB S publishers and Distributors; New Delhi: 1997.
8. Satinder A, Henrik R, Editors. HPLC method development for pharmaceuticals, vol. 8, Elsevier publishers; Noida: 2007.
9. Snyder LR, Kirkl and JJ and GlajchJL, Editors. Practical HPLC method development, 2nded. Willey International Publication: 1997.
10. Satinder A, Michael WD, Editors. Hand book of pharmaceutical analysis by HPLC, Vol. 6, Elsevier; NewDelhi: 2009.
11. Greibrokk T, Andersen T. High-temperature liquid chromatography.
12. Journal of Chromatography A. 2003; 1000(1-2): 743-755.
13. Mc Loughlin DA, Olah TV, Gilbert JD. A direct technique for the
Simultaneous determination of 10 drug candidates in plasma by liquid chromatography- atmospheric pressure chemicalionization mass spectrometry interfaced to a prospect solid-phase extraction system. Journal of Pharmaceutical and Biomedical Analysis.1997;15 (12): 1893 1901.
14. EDIGA SASI KIRAN GOUD et al, [IJPBS |Volume 2| Issue 4 |OCT-DEC |2012|277-283]
15. Sachin L Patil et al,[International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701]
16. Freddy H. Havaldar, Dharmendra L.Vairal. Simultaneous estimation of metformin hydrochloride, rosiglitazone and pioglitazone hydrochloride in the tablets dosage form. Int. J. Appl .Bio. Pharm.Tec.2010;1(3):1000-1005.
17. Kavitha. K. Y et al,[Journal of Chemical and Pharmaceutical Research, 2013, 5(1):230-235]
18. Pawar S, Meshram G, Jadhav R,Bansal Y.Simultaneous determination of Glimepiride and Metformin hydrochloride impurities in sustained release pharmaceutical drug product by HPLC .Der Pharma Chemica. 2010; 2(4): 157-168.
19. R. Sharma et al, [Indian J Pharm Sci. 2008 May-Jun; 70(3): 383–386.]
20. .Havele S, Dhaneshwar S. Estimation of Metformin in Bulk Drug and in Formulation by HPTLC. J Nanomedic Nanotechnolo,2010;1: 102.doi:10.4172/2157-7439.1000102
21. Parag Pathade, Imran Md, Vinod Bairagi, Yogesh Ahire. Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form. J. Pharm. Res. 2011; 4(3): 871-873
22. .Ghazala Khan, Dinesh Sahu Agrawal Y P, Neetu Sabarwal, Avnish Jain, Gupta A K. Simultaneous Estimation of Metformin and Sitagliptin In Tablet Dosage Form. Asian J. Biochem. Pharma. Res. 2011; 1(2): 352-358.
23. .Ramzia El-Bagary I, Ehab Elkady F, BassamAyoub M. Spectroflourometric and Spectrophotometric Methods for the Determination of Sitagliptin in Binary Mixture with Metformin and Ternary Mixture with Metformin and Sitagliptin Alkaline Degradation Product. Int. J. Biomed. Sci.2011; 7(1): 62-69.
24. .Ravi PratapPulla, Sastry B S, Rajendra Prasad Y, AppalaRaju N. Simultaneous Estimation of Metformin HCl and Sitagliptin Phosphate in Tablet Dosage Forms by RP-HPLC. Res. J. Pharm. Tech. 2011
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M.Meenakshi Sundari
Research Scholar, School of Pharmacy, Career Point University, Kota, Rajasthan, India.
M.Lakshmi Surekha
Professor and Dean A.M.Reddy Memorial College of Pharmacy,Vinukonda Road,
Petlurivaripalem, Narasaraopeta,Andhra Pradesh 522001, India.