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Development and validation of spectroscopic simultaneous equation method for simultaneous estimation of Azelnidipine and Valsartan in synthetic mixture

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A simple, specific, accurate and precise spectrophotometric method was developed and validated for simultaneous estimation of Azelnidipine and Valsartan in Synthetic Mixture. The wavelength of estimation for Azelnidipine was 240.00 nm and for Valsartan was 250.00 nm. Beer’s law is obeyed in the concentration range of 2-10μg/ml and 16-80μg/ml and correlation coefficient of 0.9999 and 0.9993 for Azelnidipine and Valsartan respectively. The % recovery for Azelnidipine and Valsartan were found to be 101.2 % - 101.9 % and 101.8 - 101.9 % respectively. Intraday precision of Azelnidipine and Valsartan were found to be 0.06 – 0.24 and 0.08 – 0.27 % RSD and Interday precision were found to be 0.14 – 0.33 and 0.11 – 0.37 % RSD respectively. The proposed method was also evaluated by the Assay of Synthetic mixture containing Azelnidipine and Valsartan. The % Assay was found to be 100.50 ± 0.002 for Azelnidipine and 100.87 ± 0.001 for Valsartan. Validation of proposed methods was carried out according to ICH Q2R1Guidelines. The proposed methods were found accurate and reproducible for routine analysis of both the drugs in synthetic mixture.
Title: Development and validation of spectroscopic simultaneous equation method for simultaneous estimation of Azelnidipine and Valsartan in synthetic mixture
Description:
A simple, specific, accurate and precise spectrophotometric method was developed and validated for simultaneous estimation of Azelnidipine and Valsartan in Synthetic Mixture.
The wavelength of estimation for Azelnidipine was 240.
00 nm and for Valsartan was 250.
00 nm.
Beer’s law is obeyed in the concentration range of 2-10μg/ml and 16-80μg/ml and correlation coefficient of 0.
9999 and 0.
9993 for Azelnidipine and Valsartan respectively.
The % recovery for Azelnidipine and Valsartan were found to be 101.
2 % - 101.
9 % and 101.
8 - 101.
9 % respectively.
Intraday precision of Azelnidipine and Valsartan were found to be 0.
06 – 0.
24 and 0.
08 – 0.
27 % RSD and Interday precision were found to be 0.
14 – 0.
33 and 0.
11 – 0.
37 % RSD respectively.
The proposed method was also evaluated by the Assay of Synthetic mixture containing Azelnidipine and Valsartan.
The % Assay was found to be 100.
50 ± 0.
002 for Azelnidipine and 100.
87 ± 0.
001 for Valsartan.
Validation of proposed methods was carried out according to ICH Q2R1Guidelines.
The proposed methods were found accurate and reproducible for routine analysis of both the drugs in synthetic mixture.

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