Research Article

New Stability Indicating Method for Quantification of Impurities in Amlodipine and Valsartan Tablets by Validated HPLC

Table 3

(a) % RSD of six (6) replicate injections of each impurity should be less than 10.0, theoretical plates should be NLT 1000 and tailing factor should be NMT 2.0 for system precision. (b) % RSD of six (6) sample preparations for each impurity should be less than 10.0 for method precision.
(a)

 System precision
AmlodipineValsartan

% RSD
Theoretical plates (N)
Tailing factor (T)
0.85
12460.23
1.034
% RSD
Theoretical plates (N)
Tailing factor (T)
0.89
617503.71
1.045

(b)

Method precision 5/320 mg

Amlodipine impurity-A
% RSD
1.06Valsartan impurity-B
% RSD
0.83