PARAMETERS OBSERVATION
Ezetimibe Atorvastatin
SPECIFICITY No Interference was found w.r.t. excipients
LINEARITY (R)5 0.9992 0.9994
RANGE 70 – 130 % of test concentration
PRECISION (RSD)*  
a) Repeatability (n=6)
    (system precision)
b) Intermediate Precision
    (inter-analyst) (n=6)
c) Method Precision (n=6)
  0.63   1.27 1.70   0.25   0.53
          
1.26
ACCURACY (% Recovery)** 100.67 ± 1.70 100.11 ± 1.8
STABILITY IN ANALYTICAL SOLUTION Stable
STRESS DEGRADATION The Peaks were Pure without any interference
ROBUSTNESS (Overall RSD)***
a) Change in Wavelength
  • 245 nm
  • 235 nm
b) Change in Flow rate
  • 1 ml/min
  • 1.2 ml/min
c) Change in Organic Conc.
  • - 2%
  • + 2%
d) Change in Column Temp.
  • 25°C
  • 35°C
e) Change in pH of Buffer
  • 3.8
  • 4.2
Less than 2%
0.81 0.35
1.37 0.36
 
0.48 0.159
0.92 0.189
 
0.09  0.10
0.049 0.08
 
0.49 0.21
0.39 0.125
 
0.39 0.028
0.16 0.16
RUGGEDNESS(Overall RSD)*** 0.94 0.90
Acceptance Criteria: RSD = 2 %. ** Acceptance mean recovery: for 80 120 %.
*** Acceptance Criteria: RSD = 2 %
Table 3: Summary of Validation Parameters.