Bio-Analytical Method Development of Repaglinide Drug Delivery Systems
Abstract
A sensitive, specific and rapid high-performance liquid chromatography-ultraviolet spectroscopy method was developed and successfully validated to estimate the repaglinide in rabbit plasma. The solvent extraction method was used for repaglinide from serum by using ethyl acetate and 0.1N HCl. The mobile phase consists of acetonitrile: phosphate buffer pH 4.0 at 60:40 %v/v with 1% triethylamine at flow rate of 0.8ml/min and at fixed wavelength of 254nm. On ten minutes of run time, repaglinide was retention at 7.4min. The extraction efficiency 95% for repaglinide. The intra-day and inter-day precision was in the terms of %RSD less than 1.76%. The developed method was validated and proposed method is useful for pharmacokinetics studies.
Keywords: Anti-diabetics, HPLC,Methanol,Phosphate buffer, Repaglinide
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References
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2. Kaushal N, Jain S, Tiwary AK. Development of spectrofluorimetric and HPLC methods for in vitro analysis of repaglinide. Indian J Pharm Sci. 2010; 72 (2): 240244.
3. Anju GI, Singhvi. Visible spectrophotometric methods for estimation of repaglinide in tablet formulation. Indian J Pharm Sci. 2006; 68(5): 656-657.
4. Jain SK, Agrawal GP, Jain NK. Spectrophotometric determination of repaglinide in tablet dosage forms. Indian J Pharm Sci. 2005; 67 (2): 249-251.
5. Jing Y, Qin SY, Rong ZL, Hong SJ. Development of an rp-hplc method for screening potentially counterfeit anti-diabetic drugs. J Chromatogr B. 2007; 853: 254– 259.
6. Prameela R, Balasekaran C, Archana N, Sivateja P, Aruna B. Determination of repaglinide in pharmaceutical formulations by rp-hplc method. J Appl Sci Res. 2009; 5(10): 1500-1504.
7. Abu-bakar R, Suhaimi M, Wahab IA, Ismail A, Huagana S. Method development and validation of repaglinide in human plasma by hplc and its application in pharmacokinetic studies. J Pharmaceut Biomed Anal. 2007; 43: 1831–1835.
8. Guidance for Industry. Extended release solid oral dosage forms: development, evaluation and application of in vitro/in vivo correlations. In U.S.D.O.H.A.H. Services, F.A.D. Administration, and CDER (eds.), Rockville, MD, 1997.
9. Uppoor VR. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J Control Rel. 2001; 72:127-132.
10. Guidance for Industry. Dissolution testing of immediate release of solid oral dosage forms. (1997).
11. Dutta S, Qiu Y, Samara E, Cao G, Granneman GR. Once-a-day extended-release dosage form of divalprox sodium III: development and validation of a Level A in vitro-in vivo correlation (IVIVC). J Pharm Sci. 2005; 94:1949-1956.
12. Jantratid E, DeMaio V, Ronda E, Mattavelli V, Vertzoni M, Dressman JB. Application of biorelevant dissolution tests to the prediction of in vivo performance of diclofenac sodium from an oral modified-release pellet dosage form. Eur J Pharm Sci. 2009; 37:434-441.
13. Modi NB, Lam A, Lindemulder E, Wang B, Gupta SK. Application of in vitro-in vivo correlations (IVIVC) in setting formulation release specifications. Biopharm Drug Dispos. 2000; 21:321-326.
14. Sirisuth N, Augsburger LL, Eddington ND. Development and validation of a nonlinear IVIVC model for a diltiazem extended release formulation. Biopharm Drug Dispos. 2002; 23:1-8.
15. Pedersen VP, Gobburu JV, Meyer MC, Straughn AB. Carbamazepine level-A in vivo-in vitro correlation (IVIVC): a scaled convolution based predictive approach. Biopharm Drug Dispos. 2000; 21:1-6.
16. Baumgartner S, Kristal J, Vrecer F, Vodopirec P, Eorko B. Optimization of floating matrix tablets and evaluation of their gastric residence time. Int J Pharm. 2000; 195: 125-135.
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1.
Ramu B, Chandrul KK, Pandiyan PS. Bio-Analytical Method Development of Repaglinide Drug Delivery Systems. JDDT [Internet]. 15Nov.2019 [cited 19Apr.2024];9(6):140-2. Available from: https://jddtonline.info/index.php/jddt/article/view/3718
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