HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN AND FENOFIBRTAE IN BULK AND PHARMACEUTICAL FORMULATION
Keywords:Rosuvastatin, Fenofibrate, HPTLC, Validation, ICH Q2 (R1)
Objective: Simultaneous quantification of Rosuvastatin and Fenofibrate tablets by HPTLC method was developed and validated as per International Conference on Harmonization [(ICH) Q2 (R1)] guideline. Methods: The chromatograms were developed using a mobile phase of ethyl acetate: acetic acid (20: 0.2, v/v) on aluminium pre-coated plates of silica gel G F254 of TLC plates and quantified by densitometric absorbance mode at 246 nm. Results: The Rf values were 0.31 Â± 0.01 and 0.76 Â± 0.01 for Rosuvastatin and Fenofibrate, respectively. The linearity of the method was found to be in the concentration range of 50-800 ng/band for both drugs. The limits of detection and quantification were 11.07 and 33.56 ng/band for Rosuvastatin and 12.76 and 38.68 ng/band for Fenofibrate. Conclusion: Developed densitometric method was found to be robust, precise, accurate, rapid and can be used to analyse fixed-dose tablet samples of Rosuvastatin and Fenofibrate.
Indian Pharmacopoeia, Indian Pharmacopoeial Commission, Published by the controller of publication Gaziabad, 2007;3:1676.
Martindale:The Complete drug reference. Pharmaceutical Press, 2006;35:1154.
British Pharmacopoeia, British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency, Stationary Office, London, 2009;2456.
The Merck Index:An encyclopedia of chemicals, drugs and biological, Merck and Co., 1996;14:3978.
Safwan A, Soulafa O. Validated high-performance liquid chromatographic method for the estimation of rosuvastatin calcium in bulk and pharmaceutical formulations. Int J Biomed Sci 2011;7(4):283-88.
Anuradha KG, Vishal DS. Development and validation of a stability-indicating reversed-phase HPLC method for simultaneous estimation of rosuvastatin and ezetimibe from their combination dosage forms. Eurasian. J Anal Chem 2010;5(3):265-83.
Dipali T, Amol MR, Pradeep DB, Anil NM, Amol VG, Vishal RB. Development and validation of a RP-HPLC-PDA method for simultaneous determination of rosuvastatin calcium and amlodipine besylate in pharmaceutical dosage form. J Chem Pharm Res 2012;4(5):2789-94.
Naman D, Avani S, Aruna S, Dave JB, Patel CN. Validated RP-HPLC method for simultaneous estimation of rosuvastatin Calcium and telmisartan in pharmaceutical dosage form. J Chem Pharm Res. 2010;2(2):252-63.
Jain PS, Kale NK, Surana SJ. Quantitative estimation of rosuvastatin in bulk and tablet dosage form by using area under curve method. J Pharm Bio Sci 2013;4:128-33.
Reddy SA, Chandrasekhar KB. Development of a UV-spectrophotometric method for the simultaneous determination of rosuvastatin calcium and aspirin in tablets. JGTPS 2012;3(1):542-49.
Shah BB, Patel BB, Gohil KN, Patel PM. Difference spectrophotometric method development and validation for simultaneous estimation of rosuvastatin calcium and telmisartan in bulk and combined dosage form. Int J Res Pharm Sci 2012;2(2):106-14.
Devi SU, Latha EP Guptha CV, Nagendra K, Ramalingam P. Development and validation of HPTLC method for estimation of rosuvastatin calcium in bulk and pharmaceutical dosage. Int J Pharma Bio Sci 2011;2(2):134
Pallavi HT, Vadalia KR, Dedania ZR. Development and validation of HPTLC method for simultaneous estimation of rosuvastatin calcium and aspirin in capsule dosage form. Int J Pharm Sci Res 2012;3(10):3867-70.
Hiral JP, Bhanubhai NS. Method development and validation of LC and Densitometric-TLC for simultaneous estimation of rosuvastatin calcium and ezetimibe in combined dosage forms. J Der Pharma Chemica 2013;5(3):208-15.
Zzaman MT, Khan SA, Arora A, Ahmad O. Method development and validation of fenofibrate by HPLC using human plasma. Rev Electron Biomed/Electron J Biomed 2009;3:41-54.
Ankit A, Shrikalp D, Pranav P, Keyur P, Sagar S, Kinjal R. A reverse phase high performance liquid chromatographic (HPLC) method for simultaneous determination of atorvastatin, ezetimibe and fenofibrate in commercial tablets. Int J Pharm Pharm Sci;4(1):206-09.
Prathyusha M, Sujitha, Sandhya M, Maheshwara Rao VU. Method development and validation for the simultaneous estimation of metformin and fenofibrate by RP-HPLC method in marketed formulation. Int J Pharm 2014;4 (1):219-25.
Krishna RG, Sonali SA, Prashant RR, Sudhir GW. Validated spectrophotometric determination of fenofibrate in formulation. J Der Pharmacia Sinica 2010;1 (1):173-78.
Dhabale PN, Gharge DS. Simultaneous spectrophotometric estimation of atorvastatin and fenofibrate in bulk drug and dosage form by using simultaneous equation method. Int J Chem Tech Res 2010;2(1):325-28.
Gupta KR, Wankhede SB, Wadodkar SG. A validated high performance thin layer chromatographic determination of fenofibrate. Indian J Pharm Sci 2005;67(6):762-64.
Komsta L, Misztal G. Determination of fenofibrate and gemfibrozil in pharmaceuticals by densitometric and videodensitometric thin-layer chromatography. J AOAC Int 2005;88(5):1517-24.
Sevda RR, Ravetkar AS, Shirote PJ. UV Spectrophotometric estimation of rosuvastatin calcium and fenofibrate in bulk drug and dosage form using simultaneous equation method. Int J Chem Tech Res 2011;3(2):629-35.
Prashant SM, Pratik RP, Kapil MA, Sanjay JS. Q-Absorbance and multicomponent UV-spectrophotometric methods for simultaneous estimation of rosuvastatin calcium and fenofibrate in pharmaceutical formulation. J Der Pharmacia Lettre 2012;4 (4):1054-59.
Swetha A, Venkateswara rao P, Sudhakar babu AMS, Pramod N. Simultaneous estimation of rosuvastatin calcium and fenofibrate in pharmaceutical dosage forms by using RP-HPLC method. Int J Bio Pharm Res 2012;3(7):935-41.
Devika GS, Sudhakar M, Venkateshwara Rao J. A new improved RP-HPLC method for simultaneous estimation of rosuvastatin calcium and fenofibrate in tablets. Int J Pharm Pharm Sci 2011;3(4), 311-15.
International Conference on Harmonization, ICH harmonized tripartite guideline validation of analytical procedures:text and methodology Q2 (R1) ICH, Geneva, 2005.