A RAPID VALIDATED UNI-DIMENSIONAL DOUBLE DEVELOPMENT HPTLC-DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE, GLICLAZIDE AND PIOGLITAZONE HYDROCHLORIDE
Objective: To develop and validate a uni-dimensional double development high performance thin layer chromatography (UDDD-HPTLC) for estimation of anti-diabetic medicine compromising of metformin (MET) gliclazide (GLZ) and pioglitazone hydrochloride (PIO).
Methods: The chromatographic separation of these drugs was carried out on precoated TLC plates silica gel 60F254by two mobile phases consisting of Ammonium Sulphate: Methanol: Acetonitrile: Water (4:3:2:1) for MET and PIO and Toluene: Ethyl Acetate: Formic Acid (6:4:0.5) for GLZ respectively for ideal separation and good resolution. The densitometric detection and quantification were carried out at 237nm for MET and 200nm for GLZ and PIO. The validation parameters were strictly followed as per the ICH guidelines.
Results: The linearity range was obtained at 3000-8000ng/spot, 360-960 ng/spot, 90-240 ng/spot for MET, GLZ and PIO with r2value >0.999. The other parameters such as precision, reproducibility, robustness were efficiently obtained within the limits. The proposed method was successfully applied for simultaneous determination of MET, GLZ and PIO in the commercial formulation.
Conclusion: In simultaneous estimation the different polarity of drugs makes it more cumbersome to develop and validate any chromatographic method. In the present study, a uni-dimensional double development high performance thin layer chromatography (UDDD-HPTLC) for estimation of these drugs have been developed and validated to resolve the estimation problem. It is an effortless and speedy method which was developed and validated using ICH guidelines. The developed and validated method using ICH guidelines is effortless and speedy technique.
2. Tripathi KD. Essential of Medical Pharmacology 5th Edn., Jaypee Brothers Medical publisher. New Delhi; 254-73.
3. Satoskar R, Rege N, and Bhandarkar S.Pharmacology and pharmaco therapeutics (Elsevier Health Sciences: 2015).
4. Lippincott Williams and Wilkins, Wilson and Gisvolds textbook, organic medicinal and pharmaceutical chemistry. 11th edition. 2002, 668-70.
5. USP 36 NF31, U. S. Pharmacopoeia National Formulary 31-Official monographs /Pioglitazone and Glimepiride. 2013;4807 and 3730
6. Goswami L, Mukhopadhyay S, and Durgapal S.Simultaneous estimation of metformin and pioglitazone by ultraviolet spectrophotometry IJPS 2010; 72:508-10.
7. Sujana K, Swathi G, Rani, M. Bhanu Prasad, M. Saheethi Reddy and Sujana K. Simultaneous estimation of pioglitazone hydrochloride and metformin hydrochloride using UV spectroscopic method J Biomed Sci and Res 2010;2:110-15.
8. Havele OS, Havele SS.Simultaneous determination of atorvastatin calcium and pioglitazone hydrochloride in its multicomponent dosage forms by UV spectrophotometry Int J Pharm Pharm Sci 2011;1:75-9.
9. Basniwal P, Srivastava P, and Jain D. Spectrophotometric estimation of pioglitazone hydrochloride in tablet dosage form AJP 2008;2:225-7.
10. Rathod SD, Patil PM, Jadhav SB and Chaudhari PD.UV spectrophotometric simultaneous determination of metformin hydrochloride and pioglitazone hydrochloride in combined dosage form AJPA 2012;2: 05-9.
11. Jain D, Jain S,Jain D, and Maulik Amin. Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride, and glimepiride by RP-HPLC in tablet formulation JCS 2008;46:501-4.
12. Mahatma ATO,Joshi M. A validated RP-HPLC method for simultaneous determination of metformin HCl, pioglitazone HCl and glimepiride in pharmaceutical formulation. J Pharmaceut Res Opin 2014;3:82-96.
13. P Raja, Thejaswini JC, Gurupadayya BM and K. Sowjanya. Determination and validation of metformin, glimepiride, and pioglitazone using atorvastatin as an Internal standard in bulk drug and pharmaceutical dosage form JACR 2011;18:61-8.
14. Patel JR, Suhagia BN, and Patel MM. Simultaneous estimation of glimepiride and pioglitazone in bulk and in pharmaceutical formulation by HPTLC method Asian J. Chem 2006;18:2873-8.
15. Jiladia M, Pandya S, and Viidyasagar G. A.simple and sensitive HPTLC method for estimation of pioglitazone In bulk and tablet dosage forms AJRC 2009;2:207-9.
16. Sujana K, Swathi Rani G, Bhanu Prasad M, Reddy MS. Simultaneous Estimation of Pioglitazone Hydrochloride and Metformin Hydrochloride using UV Spectroscopic Method J Biomed Sci and Res 2010;2:110-5.
17. Goswami L, Mukhopadhyay S, Durgapal S. Simultaneous estimation of metformin and pioglitazone by ultraviolet spectrophotometry Indian J Pharm Sci 2010;72:508-10.
18. Jajow Swapna, Chandaka Madhu, Mallepelli Srivani, Sumalatha M, Nehalatha Y. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC Asian J Pharm Ana 2012; 2:85-9.
19. Lakshmi KS, Rajesh T, Sharma S.Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms IJPPS 2009;1: 162-6.
20. Sahoo PK, Sharma R, Chaturvedi SC. Simultaneous Estimation of Metformin Hydrochloride and Pioglitazone Hydrochloride by RPHPLC Method from Combined Tablet Dosage Form Indian J Pharm Sci 2008;70:383-86.
21. Srinivas P, Venkataramana K, Mangamma K.Simultaneous determination of metformin and pioglitazone tablets in pharmaceutical dosage form by RP-HPLC method. International JPCBS 2012;2:104-9.
22. Jain D, Jain S, Jain D, Amin M.Simultaneous Estimation of Metformin Hydrochloride, Pioglitazone Hydrochloride, and Glimepiride by RP-HPLC in Tablet Formulation J Chromatogr Sci 2008;46:501-4.
23. Freddy HH, Vairal DL. Simultaneous estimation of metformin hydrochloride, rosiglitazone and pioglitazone hydrochloride in the tablets dosage form Int J Appl Biol Pharm 2010;7:1326-33.
24. Sultana N, Saeed Arayne M, Nighat S, Siddiqui FA, Hussain A. Development and Validation of New Assay Method for the Simultaneous Analysis of Diltiazem, Metformin, Pioglitazone and Rosiglitazone by RP-HPLC and its Applications in Pharmaceuticals and Human Serum J Chromatogr Sci 2011;49:774-9.
25. Sankar ASK, VetrichelvanTV, Venkappaya D.Simultaneous quantification and validation of five antidiabetic and hyperlipidemic drugs using isocratic RP-HPLC and its application to the marketed formulations J Pharm Res 2012;5:1217-20.
26. Ketan PD, Parthika AN, Agrawal YK. Development and validation of spectrophotometric method for simultaneous estimation of gliclazide and metformin hydrochloride in bulk and tablet dosage form by simultaneous equation method IJPSR 2011;2:1559-63.
27. Dhabale PN, Seervi CR.Simultaneous UV Spectrophotometric Method for Estimation of Gliclazide and Metformine Hydrochloride in Tablet Dosage Form. Journal of Chem Tech Research 2010;2:813-17.
28. Radhika B, Rahul B, Mahendra KS, Vipin S, Bhat K UV-spectrophotometric-assisted chemometric methods for the simultaneous determination of metformin hydrochloride and gliclazide in pharmaceutical formulations Pharmaceut Anal Acta 2012;3:1-5.
29. El-Wasseef DR. Simultaneous determination of metformin, nateglinide and gliclazide in pharmaceutical preparations using micellar liquid chromatography Int J Biomed Sci.2012; 8:144-51.
30. Fatema K, MdZakiur R, Tasnuva H, Mohammad Abdul KA, Reza MS. Development and validation of a simple method for simultaneous estimation of metformin hydrochloride and gliclazide in tablets by using reversed phase high performance liquid chromatography Dhaka University J. Pharm. Sci.2010;9: 83-9.
31. Vasudevan M, Ravi J, Ravisankar S, Suresh B.ION-pair liquid chromatography technique for the estimation of metformin in its multicomponent dosage forms J Pharm Biomed Anal 2001;25:77-84.
32. Elkady, Ehab & El-Zaher, Asmaa & Elwy, Hanan mohamed & Saleh, Mahmoud. Validated Liquid Chromatographic Method for Simultaneous Determination of Metformin, Pioglitazone, Sitagliptin, Repaglinide, Glibenclamide and Gliclazide - Application for Counterfeit Drug Analysis J Anal Bioanal Tech 2015;2155-9872.
33. Anusha Akula, Prajwala N, Sandhya M, Rao DUM. Development and validation of RP-HPLC method for simultaneous estimation of metformin hydrochloride and gliclazide in bulk and combined doasage form IJPPS 2013;5:511-7.
34. Maria-cristinaR, Mihaela I, Lavinia H, Elena I, Valentina A. Validation of a HPLC method for the simultaneous analysis of metformin and gliclazide in human plasma Farmacia 2009;57:728-35.
35. Zhong GP, Bi HC, Zhou S, Chen X, Huang M. Simultaneous determination of metformin and gliclazide in human plasma by liquid chromatography-tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy volunteers J Mass Spectrom 2005;40:1462-71.
36. Chaturvedi PK, Sharma R. Simultaneous spectrophotometric estimation and validation of three component tablet formulation containing pioglitazone hydrochloride, metformin hydrochloride and glibenclamide Analytical Letters 2008; 41:2133-42.
37. Narsimha Rao D, Shanmugasundaram P, Vaishnav H. Method Development and Validated of Simultaneous Estimation of Metformin Hydrochloride, Pioglitazone Hydrochloride and Glibenclamide in Pure and Tablet dosage form by Spectrophotometric Multi component Method Int J Chemtech Res 2011;3:2011-17.
38. Dhole SM, Pramod BK, Amnerkar ND. UV Spectrophotometric Absorption Correction Method for the Simultaneous Estimation of Pioglitazone HCl, Metformin HCl and Glibenclamide in Multicomponent Formulation Int J Anal Bioanal Chem 2013;3:18-22.
39. Ranetti MC, Ionescu M, Hinescu L, Ionica E, Anuta V, Ranetti AE. Validation of a HPLC method for the simultaneous analysis of metformin and gliclazide in human plasma Farmacia 2009;57:728-35.
40. Rao BU, Nikalje AP. Determination of gliclazide in a tablet dosage form in the presence of metformin hydrochloride by ion pair reversed phase liquid chromatographic technique Afr J Pharm Pharmacol 2011;5:1331-1337.
41. S AbuRuz, J Millership, J McElnay. The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma J Chromatogr B 2005;817: 277-286.
42. T Eva, D Leonard, B Gëzim. Ion-pair HPLC method for the quantification of metformin in human urine J Appl Bioanal 2016;2:16-24.
43. D.R. El-Wasseef. Simultaneous determination of metformin, nateglinide and gliclazide in pharmaceutical preparations using micellar liquid chromatography Int J Biomed Sci 2012;8:144-151.
44. Szabady B. The different modes of development in Planar Chromatography. Springer Budapest. 2001;88
45. Poole CF, Poole SK, Fernando WP N. Multidimensional and multimodal Thin Layer Chromatography: pathway to the future.J. Planar Chromatogr 1989;332:6.
46. IPM Biotech ICH Topic Q 2 B. Validation of Analytical Procedures: Methodology1996.
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