A VALIDATED STABILITY INDICATING UV-SPECTROPHOTOMETRIC SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND FENOFIBRATE IN BULK AND PHARMACEUTICAL FORMULATION

Authors

  • APEKSHA FUNDE Department of Pharmaceutics, Abasaheb Kakade College of B. Pharmacy, Bodhegaon 414503, Ahmednagar, Maharashtra
  • JAYSHREE KOKAT Department of Pharmaceutical Chemisrty, Abasaheb Kakade College of B. Pharmacy, Bodhegaon 414503, Ahmednagar, Maharashtra

DOI:

https://doi.org/10.22159/ijcr.2021v5i1.144

Keywords:

Correlation coefficient , Detection limit, Precision, Pharmaceutical, Quantification limit, Spectrophotometric, Ultraviolet, λ max, % RSD

Abstract

Objective: The present work deals with the development and validation of the absorbance ratio method for the estimation of rosuvastatin calcium and fenofibrate in bulk and pharmaceutical formulation. Studied forced degradation characteristics of bulk and pharmaceutical formulation as per stability guidelines.

Methods: The bulk and pharmaceutical formulation studied by the absorbance ratio method. It is the ratio of absorbances at two selected wavelengths. One wavelength is the isoabsorptive point and another wavelength is λ max of one of the components. From the overlay spectra of the two drugs, ROS and FEN showed the isoabsorptive point at 249.5 nm. The second wavelength used was 287 nm, which was the λ max of FEN.

Results: The drugs obeyed Beer's law and showed a good correlation. The correlation coefficient for the ROS was 0.999 and for FEN 0.999. The RSD for intraday precision was 0.57 for ROS and 0.057 for FEN. The interday precision was 0.05 for ROS and 0.03for FEN, respectively. The detection limit and quantification limit were found to be 0.048 and 0.14 μg/ml for ROS and 0.069 and 0.21μg/ml for FEN, respectively. More degradation was found in acid hydrolysis and photostability degradation.

Conclusion: A simple, precise, accurate, validated, stability-indicating method for simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and pharmaceutical formulation has been developed.

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References

Bai MD. A comparative study of the efficacy of rosuvastatin and atorvastatin in combination with fenofibrate in dyslipidemia. Int J Sci Res 2016;51:211-4.

Sharma A, Pokra M, Bhargava AK. Comparative study of atorvastatin and rosuvastatin on serum lipid profile in cardiac patients with diabetes. Med Sci Clin Res 2018;6:288-97.

Rohit D, Shankar J. Comparative study of atorvastatin and rosuvastatin in combination with fenofibrate in mixed hyperlipidemia. Int J Pharmacol Clin Sci 2016;5:25-31.

Strain JD, Farver DK, Clem JR. A review of the rationale and clinical use of concomitant rosuvastatin and fenofibrate therapy. Clin Pharm Adv Appl 2010;2:95-104.

Anandakumar K, Vetsa S, Ramu C, Jayamaryapan M. Simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and tablet dosage form by UV-spectrophotometry and RP-HPLC. Stamford J Pharm Sci 2011;4:58-63.

Sevda RR, Ravetkar AS, Shirote PJ. UV-spectrophotometric estimation of rosuvastatin calcium and fenofibrate in bulk drug and dosage form using the simultaneous equation method. Int J Chem Res 2011;3:629-35.

Potawale RS, Gabhe SY. Hptlc method for simultaneous determination of rosuvastatin and fenofibrate in bulk and pharmaceutical formulation. Int J Pharm Pharm Sci 2014;6:323-6.

Sharma S. Simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and tablet dosage form by UV-spectrophotometry and RP-HPLC. J Pharm Res 2012;5:2311-4.

Borole TC, Dewani MG, Gandhi SP, Damale MC. Simultaneous estimation of rosuvastatin calcium and fenofibrate in their combined tablet dosage form by HPLC method. Asian J Res Chem 2011;4:1557-61.

Patel H, Rathode R, Dash RP. Simultaneous quantification of rosuvastatin and fenofibric acid by HPLC-UV in rat plasma and its application to a pharmacokinetic study. J Liq Chrom Tech 2014;37:1673-84.

Trivedi RK, Kalem RR, Mulangi R, Shrinivas RR. Simultaneous determination of rosuvastatin and fenofibric acid in human plasma by LC-MS/MS with electrospray ionization: assay development, validation, and application to a clinical study. J Pharm Biomed Anal 2005;15:3-4.

Kumar SA, Debnath M, Sankar DC. Development and validation of a sensitive RP-HPLC method for simultaneous estimation of rosuvastatin and fenofibrate in tablet dosage form by using PDA detector in gradient mode. Res J Pharm Tech 2016;9:549-54.

Vyas S, Raval K, Antala H. Development and validation of the derivative spectroscopic method for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined dosage form. Int J Res Pharm Nano Sci 2013;2:158-68.

Chaudhary J, Jain A, Saini V. Simultaneous estimation of multicomponent formulations by UV-visible spectroscopy: an overview. Int Res J Pharm 2011;2:81-3.

Singh S, Rai J, Choudhary N, Sharma S. Stability-indicating UV-vis spectrophotometric method for estimation of atorvastatin calcium and fenofibrate in tablet dosage form. Bulletin Pharm Res 2012;2:159-66.

Turabi ZM, Khatatbeh OA. Stability indicating RP-HPLC method development and validation for the determination of rosuvastatin in pharmaceutical dosage form. Int J Pharm Sci Drug Res 2014;6:154-9.

Ranjeet KV, Sai MD, Ajitha A, Uma MR. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of atorvastatin and olmesaratn in the pharmaceutical dosage form. Int J Pharm Res Anal 2014;4:282-387.

Ranjit S. Zia R. Current trends in forced degradation study for pharmaceutical product development. J Pharm Edu Res 2012;3:54-63.

Published

01-01-2021

How to Cite

FUNDE, A., and J. KOKAT. “A VALIDATED STABILITY INDICATING UV-SPECTROPHOTOMETRIC SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND FENOFIBRATE IN BULK AND PHARMACEUTICAL FORMULATION”. International Journal of Chemistry Research, vol. 5, no. 1, Jan. 2021, doi:10.22159/ijcr.2021v5i1.144.

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Section

Research Article