Abstract:
A simple, accurate, and precise UV spectroscopy and RP-HPLC methods were
developed and validated for simultaneous estimation of Atorvastatin Calcium and
Irbesartan in their Pharmaceutical Dosage Form. A simple and sensitive UV
spectrophotometric method has been developed by Simultaneous equation method in
which determination was carried out at 246nm λmax of Atorvastatin Calcium and
228nm λmax of Irbesartan. The calibration curves were linear in a concentration range
of 6-26 μg/ml for Atorvastatin Calcium and 8-18 μg/ml for Irbesartan at their
respective wavelength. In the combined Dosage Form both the drugs were estimated
as 99.20% and 99.66% Atorvastatin Calcium and Irbesartan respectively. The RPHPLC
method was performed on ProntoSIL C18 column (150mm X 4.6 mm i.d., 5
μm particle size) with a gradient system of Acetonitrile : Buffer (pH 3.5) in the ratio
of 55:45 v/v with a flow rate of 1.0 ml/min, injection volume 20μl and detection
wavelength was 245nm. The retention time for Atorvastatin Calcium and Irbesartan
was obtained as 5.930±0.05min and 2.92±0.1min respectively. The linearity of the
proposed method was investigated in the range of 2-10μg/ml and 15-75μg/ml for
Atorvastatin Calcium and Irbesartan respectively. Correlation coefficient was 0.9992 and 0.9994 for Atorvastatin Calcium and Irbesartan respectively. The developed
method was validated as per ICH guidelines, for its accuracy, precision, LOD & LOQ
and satisfactory results were obtained, thus the method is specific, rapid, and sensitive
for estimation of Atorvastatin Calcium and Irbesartan.
