Abstract:
A First order derivative spectroscopic method and RP-HPLC method were developed
and validated for simultaneous estimation of Rosuvastatin Calcium, Clopidogrel
Bisulphate and Aspirin in Pharmaceutical Dosage form. First order derivative method
based on the measurement of absorbance at three wavelengths 362.49nm, 224.05nm and
288.45nm i.e. Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin respectively.
The calibration curve was linear in a concentration range of 2-14μg/ml for Rosuvastatin
Calcium, 7.5-52.5μg/ml for Clopidogrel Bisulphate and 7.5-52.5μg/ml for Aspirin. The
RP-HPLC method has shown adequate separation of Rosuvastatin Calcium, Clopidogrel
Bisulphate and Aspirin in Pharmaceutical Dosage form. The separation was achieved on
a Luna C18 (250mmX4.6 mm i.d., 5μm particle size) with an Isocratic system of
Acetonitrile: Buffer (0.05M Potassium Dihydrogen Phosphate and pH 3 was adjusted
with Ortho phosphoric Acid) in the ratio of 60:40v/v, flow rate was at 1.0 ml/min, and
wavelength of detection used was 238nm. The retention time for Rosuvastatin Calcium,
Clopidogrel Bisulphate and Aspirin was obtained as 2.030±0.027min, 3.681±0.0259 and
6.293±0.028 respectively. The linearity of the proposed method was investigated in the
range of 10-60μg/ml, 37.5-225μg/ml and 37.5-225μg/ml for Rosuvastatin Calcium,
Clopidogrel Bisulphate and Aspirin respectively. Correlation coefficient was 0.998, 0.998
and 0.999for Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin respectively.
The developed method was validated as per ICH guideline, for its linearity, accuracy,
precision, and robustness the results were found to be satisfactory. Thus, the method is
specific, rapid and simple for estimation of Rosuvastatin Calcium, Clopidogrel
Bisulphate and Aspirin.