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


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

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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