An Improved Efficient Chromatographic Development and Validation for Quantitative Determination of Rosuvastatin Calcium and Cholecalciferol in Solid Pharmaceutical Tablets Dosage Forms
Keywords: Rosuvastatin calcium, Cholecalciferol, limit of detection , limit of quantification, Validation.
AbstractThe simple, reliable, sensitive and isocratic analytical chromatography was developed for the estimation, separation and validation of both the drugs rosuvastatin calcium and cholecalciferol in tablets dosage forms. Chromatographic elution was attained by C18 thermo, 250 x 4.6 mm column, with particle size 5 μm and 1.5 mL per minute flow rate using mobile phase as methanol : acetonitrile : triethanolamine (55:45:0.4%). Detection of both drugs were monitored at 265 nm. The retention time of rosuvastatin calcium and cholecalciferol were 1.336 and 6.031 minutes, respectively and overall chromatographic run time was approximately 20 minutes. The establishment of linearity was done in concentration of 70–130 μg/mL ( r2 = 0.995) and 7–13 IU ( r2 = 0.983), respectively in rosuvastatin calcium and cholecalciferol. The limit of detection (LoD) 0.88 and 0.11 and limit of quantification (LoQ) was 2.66 and 0.34 for rosuvastatin calcium and cholecalciferol, respectively. Accuracy (recovery) was between 94.34 to 103.51% and 100.82 to 102.46% for rosuvastatin calcium and cholecalciferol, respectively. The developed and validated chromatographic method was within the acceptable limits for both the drugs with precision, robustness, accuracy, ruggedness, and stability of the solution and the relative standard deviation was less then 2. The proposed chromatographic method is precise, accurate, rapid, time effective, simple, reproducible for routine quantitative estimation of both the drugs rosuvastatin calcium and cholecalciferol in solid pharmaceutical tablets dosage forms
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