Compound Relative Retention Time Lab Report
SPECIFICITY
Compound Relative retention time
Related sustances From individual solution From blend solution Varation
H-GTBRC01 (0.15%) 0.65 0.65 0.00
H-GTBRC02 (0.15%) 0.80 0.80 0.00
H-GTBRC03 (0.15%) 0.43 0.43 0.00
Gefitinib (0.1%) 1.00 1.00 0.00
Observation:
No interference was observed due to blank at the retention time of H-GTBRC01, H-GTBRC02, H-GTBRC03 .
The order & relative retention time obtained from individual solution & blend solution were matched.
Peak purity should comply for H-GTBRC01, H-GTBRC02, H-GTBRC03 from individual solution & blend solution should comparable
Peak purity passed for H-GTBRC01, H-GTBRC02, H-GTBRC03 from individual solution & blend solution were matched.
Acceptence …show more content…
Acceptance Criteria: Correlation coefficient should be more than 0.995
H-GTBRC03
Level H-GTBRC02
Conc.(%) Area of replicate-1 Area of replicate-2 Area of replicate-3 Average %RSD
Level-1 0.006 1634 1642 1626 1634 0.49
Level-2 0.076 22200 22190 21907 22099 0.75
Level-3 0.121 38462 38388 38264 38371 0.26
Level-4 0.152 48816 48872 48903 48864 0.09
Level-5 0.228 74449 74558 74184 74397 0.26
Level-6 0.303 100010 100005 100195 100070 0.11
Concentration (%)
Observation: correlation coefficient was found to be 0.999.
Acceptance Criteria: Correlation coefficient should be more than 0.995.
Observation:
Linear plot obtained each component was in the range of LOQ to 200%
%RSD calculated for the area of triplicate injections of each level of each component is within limit
correlation coefficient value of each component is within limit
Acceptance limit is:
The %RSD of peak reponse for each component is should not me more than 5
correlation coefficent should not be less than 0.995
RANGE
LOWER …show more content…
Acceptance criteria:
The variation of content(%) of H-GTBRC01, HGTBRC02, H-GTBRC03 obtained from initial (fresh) sample amd each time interval of the solution stability should be meet the criteria below:
If initial result is below 0.10%;variation should be within ±0.03 for individual impurity.
If initial result is above 0.10%;variation should be within ±0.05 for individual impurity.
If any extraneous peak of impurities or degradents are observed in chromatogram of sample than that of initial pattern consider the solution is not stable.
ROBUSTNESS RESULTS :
FLOW VARATION OF 0.6 mL/min
Reference solution
Injection no H-GTBRC01 H-GTBRC02 H-GTBRC03 Gefitinib
1 16127 69658 64150 61726
2 16181 69472 64019 61669
3 16261 70081 64647 61904
4 16250 69658 64484 61779
5 16273 69313 64551 61857
6 16154 69554 64251 61916
Average 16208 69652 64350 61808
%RSD 0.38 0.39 0.38
Compound Relative retention time
Related sustances From individual solution From blend solution Varation
H-GTBRC01 (0.15%) 0.65 0.65 0.00
H-GTBRC02 (0.15%) 0.80 0.80 0.00
H-GTBRC03 (0.15%) 0.43 0.43 0.00
Gefitinib (0.1%) 1.00 1.00 0.00
Observation:
No interference was observed due to blank at the retention time of H-GTBRC01, H-GTBRC02, H-GTBRC03 .
The order & relative retention time obtained from individual solution & blend solution were matched.
Peak purity should comply for H-GTBRC01, H-GTBRC02, H-GTBRC03 from individual solution & blend solution should comparable
Peak purity passed for H-GTBRC01, H-GTBRC02, H-GTBRC03 from individual solution & blend solution were matched.
Acceptence …show more content…
Acceptance Criteria: Correlation coefficient should be more than 0.995
H-GTBRC03
Level H-GTBRC02
Conc.(%) Area of replicate-1 Area of replicate-2 Area of replicate-3 Average %RSD
Level-1 0.006 1634 1642 1626 1634 0.49
Level-2 0.076 22200 22190 21907 22099 0.75
Level-3 0.121 38462 38388 38264 38371 0.26
Level-4 0.152 48816 48872 48903 48864 0.09
Level-5 0.228 74449 74558 74184 74397 0.26
Level-6 0.303 100010 100005 100195 100070 0.11
Concentration (%)
Observation: correlation coefficient was found to be 0.999.
Acceptance Criteria: Correlation coefficient should be more than 0.995.
Observation:
Linear plot obtained each component was in the range of LOQ to 200%
%RSD calculated for the area of triplicate injections of each level of each component is within limit
correlation coefficient value of each component is within limit
Acceptance limit is:
The %RSD of peak reponse for each component is should not me more than 5
correlation coefficent should not be less than 0.995
RANGE
LOWER …show more content…
Acceptance criteria:
The variation of content(%) of H-GTBRC01, HGTBRC02, H-GTBRC03 obtained from initial (fresh) sample amd each time interval of the solution stability should be meet the criteria below:
If initial result is below 0.10%;variation should be within ±0.03 for individual impurity.
If initial result is above 0.10%;variation should be within ±0.05 for individual impurity.
If any extraneous peak of impurities or degradents are observed in chromatogram of sample than that of initial pattern consider the solution is not stable.
ROBUSTNESS RESULTS :
FLOW VARATION OF 0.6 mL/min
Reference solution
Injection no H-GTBRC01 H-GTBRC02 H-GTBRC03 Gefitinib
1 16127 69658 64150 61726
2 16181 69472 64019 61669
3 16261 70081 64647 61904
4 16250 69658 64484 61779
5 16273 69313 64551 61857
6 16154 69554 64251 61916
Average 16208 69652 64350 61808
%RSD 0.38 0.39 0.38