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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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://mail.innovareacademics.in/journals/index.php/ijpps/article/view/2010.

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