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Development and Validation of UV Spectrophotometric Method for the Simultaneous Estimation of Rosuvastatin and Ezetimibe in Pharmaceutical Dosage Form


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1 Anurag Group of Institutions (Formerly Lalitha College of Pharmacy), Venkatapur, Ghatkesar, Medchal, Telangana-500088, India
     

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A simple, accurate, precise and economical spectrophotometric method was developed and validated for simultaneous estimation of Rosuvastatin (RST) and Ezetimibe (EZE) in combined dosage form. In simultaneous equation method, Rosuvastatin and Ezetimibe were quantified using their absorptivity values at selected wavelengths, viz; 223nm and 229nm respectively. Distilled water was used as the solvent. Different analytical performance parameters such as linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) was determined according to ICH guidelines. The linearity range was found to be 4-32 μg/ml for both the drugs. LOD and LOQ for Rosuvastatin were found to be 1.1μg/ml and 3.5μg/ml, for Ezetimibe 1.1μg/ml and 3.5μg/ml respectively.

Keywords

Rosuvastatin, Ezetimibe, Spectrophotometric Method, Method Development, Validation.
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  • https://www.drugbank.ca/drugs/DB01098
  • https://pubchem.ncbi.nlm.nih.gov/compound/Rosuvastatin
  • https://www.drugbank.ca/drugs/DB00973
  • https://pubchem.ncbi.nlm.nih.gov/compound/Ezetimibe
  • Vishal V. Rajkondwar, Pramila Maini and Monika Vishwakarma; Characterization and method development for estimation and validation of Rosuvastatin Calcium by UV – visible spectrophotometry; International Journal of Theoretical and Applied Sciences; 2009; 1(1); pg.no. 48-53.
  • Alka Gupta, P. Mishra and K. Shah; Simple UV Spectrophotometric Determination of Rosuvastatin Calcium in Pure Form and in Pharmaceutical Formulations; ECJHAO E-Journal of Chemistry; 2009; 6(1); pg.no. 89-92.
  • Gajjar Anuradha K and Shah Vishal D; Simultaneous UV Spectrophotometric Estimation of Rosuvastatin and Ezetimibe in their combined dosage forms; International Journal of Pharmacy and Pharmaceutical Sciences; 2010; 2(1); pg.no. 131-138.
  • Anuradha K. Gajjar and Vishal D. Shah; Development and Validation of a Stability-Indicating Reversed-Phase HPLC method for Simultaneous Estimation of Rosuvastatin and Ezetimibe for their Combination Dosage Forms; Eurasian Journal of Analytical Chemistry; 2010; 5(3); pg.no. 280-298.
  • Varghese, Sushell John, Ravi, Thengungal Kochupappy; Determination of Rosuvastatin and Ezetimibe in a Combined Tablet Dosage form using High-Performance Column Liquid Chromatography and High-Performance Thin-Layer Chromatography; Journal of AOAC International; 2010; 93(6); pg.no. 1222-1227.
  • Hasumati A. Raj, Sadhana J. Rajput, Jayant B. Dave and Chaggan N. Patel; Development and Validation of Two Chromatographic Stability-Indicating Methods for determination of Rosuvastatin in pure form and Pharmaceutical preparation; International Journal of Chem Tech Research; 2009; 1(3); pg.no.677-689.

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  • Development and Validation of UV Spectrophotometric Method for the Simultaneous Estimation of Rosuvastatin and Ezetimibe in Pharmaceutical Dosage Form

Abstract Views: 309  |  PDF Views: 0

Authors

D. Sireesha
Anurag Group of Institutions (Formerly Lalitha College of Pharmacy), Venkatapur, Ghatkesar, Medchal, Telangana-500088, India
M. Laksmi Monika
Anurag Group of Institutions (Formerly Lalitha College of Pharmacy), Venkatapur, Ghatkesar, Medchal, Telangana-500088, India
Vasudha Bakshi
Anurag Group of Institutions (Formerly Lalitha College of Pharmacy), Venkatapur, Ghatkesar, Medchal, Telangana-500088, India

Abstract


A simple, accurate, precise and economical spectrophotometric method was developed and validated for simultaneous estimation of Rosuvastatin (RST) and Ezetimibe (EZE) in combined dosage form. In simultaneous equation method, Rosuvastatin and Ezetimibe were quantified using their absorptivity values at selected wavelengths, viz; 223nm and 229nm respectively. Distilled water was used as the solvent. Different analytical performance parameters such as linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) was determined according to ICH guidelines. The linearity range was found to be 4-32 μg/ml for both the drugs. LOD and LOQ for Rosuvastatin were found to be 1.1μg/ml and 3.5μg/ml, for Ezetimibe 1.1μg/ml and 3.5μg/ml respectively.

Keywords


Rosuvastatin, Ezetimibe, Spectrophotometric Method, Method Development, Validation.

References