HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN AND FENOFIBRTAE IN BULK AND PHARMACEUTICAL FORMULATION

Authors

  • Rani S. Potawale Department of Pharmaceutical Chemistry, Gyan Vihar School of Pharmacy, Suresh Gyan Vihar University, Jagatpura, Jaipur-302025, Rajasthan, India. Department of Pharmaceutics, Allana College of Pharmacy, Azam Campus, Camp, Pune-411001, India
  • Satish Y. Gabhe Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University (BVDU), Pune 411038, India.

Keywords:

Rosuvastatin, Fenofibrate, HPTLC, Validation, ICH Q2 (R1)

Abstract

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 ± 0.01 and 0.76 ± 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.

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References

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.

Published

01-07-2014

How to Cite

Potawale, R. S., and S. Y. Gabhe. “HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN AND FENOFIBRTAE IN BULK AND PHARMACEUTICAL FORMULATION”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 7, July 2014, pp. 323-6, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/2010.

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