Ajay I. Patel, Krupa B. Prajapati, Swati H. Jolapara, Amitkumar J. Vyas, Ashok B. Patel, Nilesh K. Patel, Minakshi M. Pandey
Dr. Ajay I. Patel, Krupa B. Prajapati*, Ms. Swati H. Jolapara, Dr. Amitkumar J. Vyas, Dr. Ashok B. Patel, Dr. Nilesh K. Patel, Ms. Minakshi M. Pandey
B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Ajidem, Rajkot, Gujarat, India, 360003.
Volume - 14,
Issue - 6,
Year - 2021
The high-Performance Analytical Liquid Chromatography (HPLC) method (AQbD) for routine analysis of Gemfibrozil in dosage form was developed in column C18 using an experimental design. The central composite design (CCD) was adopted in evaluating the responses and robustness of the method. In the project, the combined effect of buffer pH, % organic phase and flow rate, each at five levels, was selected for responses such as retention time and number of theoretical plates, then interpreted and optimized statistically with the help of the surface methodology of response and therefore of the analysis of the constructed models and of the outline graphs was obtained. Acetonitrile: phosphate buffer (pH-4) (59: 41% v / v) as eluent at a flow rate of 1.0ml/min was found to be the optimal condition for obtaining the desired answers.
Cite this article:
Ajay I. Patel, Krupa B. Prajapati, Swati H. Jolapara, Amitkumar J. Vyas, Ashok B. Patel, Nilesh K. Patel, Minakshi M. Pandey. RP-HPLC Method for Determination of Gemfibrozil using Central Composite Design (CCD). Research Journal of Pharmacy and Technology. 2021; 14(6):3009-4. doi: 10.52711/0974-360X.2021.00527
Ajay I. Patel, Krupa B. Prajapati, Swati H. Jolapara, Amitkumar J. Vyas, Ashok B. Patel, Nilesh K. Patel, Minakshi M. Pandey. RP-HPLC Method for Determination of Gemfibrozil using Central Composite Design (CCD). Research Journal of Pharmacy and Technology. 2021; 14(6):3009-4. doi: 10.52711/0974-360X.2021.00527 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-17
1. Rang H, Dale M, Ritter and Flower R. Rang and Dale's Pharmacology: Edn 6; Elsevier Publication, New Delhi, pp665-668, 2007.
2. ICH Harmonized Tripartite Guideline: “Pharmaceutical Quality System” ICH Q10, (Switzerland 2008).
3. ICH- Harmonized Tripartite Guideline: “Pharmaceutical Development” ICH Q8 (R2), (Switzerland 2009).
4. Lawrence Y. Pharmaceutical quality by design: Product and process development, understanding and control. Pharm Res 25:781–791, 2008.
5. Lee S, Raw A, Yu. L. Significance of drug substance physiochemical properties in regulatory quality by design. In Drugs and the Pharmaceutical Sciences 78 (Preformulation in Solid Dosage Form Development), London: Informa Health- care,571–583, 2008 (http://doi.org/10.1007/s11095-007-9511-1).
6. Mhatre R, Rathore A. Quality by design: An overview of the basic concepts. In Quality by design for biopharmaceuticals. New York: Wiley, 1–8, 2009 (http://doi.org/10.1002/9780470282335).
7. Schweitzer M, Melissa M, Nethercote P , Borman P , Hansen G , Smith K, Larew J. Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharmaceutical Technology, 34(2), 2010 (http://www.researchgate.net/publication/282481497).
8. Parikh V, Karkhanis V. Spectrophotometric estimation of gemfibrozil in bulk and pharmaceutical dosage forms. Int. Res. J. Pharm., 2, 106– 109, 2010 (https://www.core.ac.uk).
9. Kang X, Wang F, Xie Z. A high performance liquid chromatography method for simultaneous determination of rosiglitazone and gemfibrozil in human plasma. J. Chromatogr. B, 2009, (https://doi.org/10.1016/j.jchromb.2009.01.001).
10. Kim C, Jae J, Hwang H, Ban E. Simple and Sensitive HPLC Method for Determination of Gemfibrozil in Human Plasma with Fluorescence Detection Determination of Gemfibrozil in Human. J. Liq. Chromatogr. Rel. Tech., 37–41, 2004, (https://doi.org./10.1080/10826070500452051).
11. Ulu S. HPLC Determination of Gemfibrozilin Tablets. J. Chromatographia., 7, 447–451, 2006, (https://doi.org.10.1365/s10337-006-0057-x).
12. González P, Agarraberes S, López-Ocariz A. Asensitive method for the determination of gemfibrozil in human plasma samples by RP-LC. J. Pharma. Biomed. Anal., 2001, (https://doi.org./10.1016/s0731-7085(01)00369-7).
13. Parikh V, Karkhanis V. Estimation of Gemfibrozilin Tablet Dosage Form by HPTLC Method. Res. J. Pharma. Bio. Chem. Sci., 2(3), 889– 898, 2011, (https://www.researchgate.net).
14. Rower J, Bushman L, Hammond K. Validation of Al C / MS method for the determination of gemfibrozil in human plasma and its application to a pharmacokinetic study. ‖ Biomed. Chromatogr., 5, 1300– 1308, 2010, (https://doi.org./10.1002/bmc.1440).
15. Randinitis E, Kinkel A, Nelson C, Parker T. Gas chromatographic determination of gemfibrozil and its metabolites in plasma and urine. J. Chromatogr. B., 307(1), 210–215, 1984, (https://doi.org./10.1016/s0378-4347(00)84090-6).
16. El-din M, Attia K, Nassar W, Kaddah M. Two different spectrofluorimetric methods for simultaneous determination of gemfibrozil and rosiglitazone in human plasma. Talanta., 82(5),1708–1716, 2010, (https://doi.org./10.1016/j.talant.2010.058).
17. Manzoori J, Amjadi A. Spectro fluorimetric and micelle-enhanced spectrofluorimetric methods for the determination of gemfibrozil in pharmaceutical preparations. J. Pharma. Biomed. Anal., 31(3),507–513,2003, (https://doi.org./10.1016/s0731-7085(02)00679-9).
18. Debrus B, Guillarme D, Rudaz S. Improved quality-by-design compliant methodology for method development in reversed-phase liquid chromatography. J. Pharm. Biomed. Anal., 84,215–223.2013, (http://dx.doi.org/10j.jpba.2013.06.013).
19. Bajaj M, Nanda S. Analytical Quality by Design (AQBD): New Paradiam for Analytical Method Development. Int. J. Develop. Res. ,5, 3589– 3599,2015, (http://doi.org/10.37118 ).
20. 2015, (http://doi.org/10.1155/2015/868727).
21. Prafulla K, Nageswara K. An over view of experimental designs in HPLC method development and validation. J. Pharma. Biomed. Anal, 2017, (http://doi.org/10.1016/j.jpba.2017.05.006
22. Leeuwen J, Nauta M, Kaste D. Risk analysis by FMEA as an element of analytical validation. J. Pharm. Biomed. Anal. 50,1085-1087,2009, (http://doi.org/10.1016/j.jpba.2009.06.049).
23. Beg S, Sharma G, Katare O. Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Estimating Olmesartan Medoxomil Using Quality by Design. J. Chromatogr. Sci. Adv., 1–12, 2015, (http://doi:10.1093/chromsci/bmu165 ).
24. Chatterjee S. QbD Considerations for Analytical Methods FDA Perspective. IFPAC Annual Meeting Baltimore, 2013, (www.fda.gov).
25. Ramalingam P, Kalva Bhadraya P. Analytical Quality by design: A tool for Regulatory Flexibility and Robust Analytics. Int. J. Anal. Chem., 2015, (http://doi.org/10.1155/2015/868727).
26. Jiprakash N, Mrinmayee D. Quality by Design approach: Regulatory need. Arab. J. Chem., 10, S3412-S3425, 2013, (http://doi.org/10.1016/j.arabjc.2014.01.025).
27. ICH- Harmonized Tripartite Guideline: “Validation of Analytical Procedures” ICH Q2 (R1) (Switzerland 2005).
28. Vogt F, Kord A. Development of Quality-By-Design Analytical Methods. Wiley Online Library (wileyonlinelibrary.com), 2010, (http://doi.10.1002/jps.22325).
29. Sridharan D, Umarani A, Thenmozil L, Kumar P, Chintalapati A, Venkata Ramanaiah M, Phinikishore Y. Development and validation of UV-Spectrophotometric method of Darifenacin Hydrobromide in bulk and tablet dosage form. Asian J. Pharm. Ana. (3), 43-45, 2011.
30. Gupta A, Rawat S, Gandhi M, Yadav J. Method development and acid degradation study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 1(1), 14-18, 2011.
31. Thenmozhi A, Sridharan D, Veeramani S, Palanivelu M. A RP-HPLC method for the estimation of Dexibuprofen in pharmaceutical tablet dosage form. Asian J. Pharm. Ana. 1(4), 98-99, 2011.
32. Satyanarayana L, Naidu S, Narasimha Rao M, Reddy L. The estimation of nilotinib in capsule dosage form by RP-HPLC. Asian J. Pharm. Ana. 1(4), 100-102, 2011.
33. Jajow S, Chandaka M, Mallepeli S, Sumalatha M, Nelatha Y, Anusha Y. Analytical method development and method validation for the simultaneous estimation of metformin hydrochloride and piogliptazone hydrochloride in tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 2(3), 85-89, 2012.
34. Solanki R, Nagori B,Naval M, Banerjee J. Development and validation for the simultaneous estimation of method for amoxicillin trihydrate and tinidazole in tablet dosage form by RP-HPLC. Asian J. Pharm. Ana.3(2), 66-71, 2013.
35. Pathi J, Appala N. The estimation of epalrestat in tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 2(2), 49-51, 2012.
36. Thangabalan B, Saloni M, Sunitha N, Manohar S. Development of validated RP-HPLC method for the estimation of itraconazole in pure and pharmaceutical dosage form. Asian J. Pharm. Ana. 3(4), 119-123, 2013.
37. Vanaja N, Preethi Ch, Manjunatha S, Pal K. method development and validation for the simultaneous estimation of telmisartan and chlorthyalidone by RP-HPLC in pharmaceutical dosage form. Asian J. Pharm. Ana. 5(4), 171-177, 2015.
38. Pathi J, Appala N. The estimation of palonoserton hydrochloride in parentrals by RP-HPLC. Asian J. Pharm. Ana. 2(2), 77-79,2012.