Table: Summary of method validation parameter results
Validation parameters Acceptance criteria Results Aminexil Minoxidil
System suitability Theoretical plates should be NLT 2000 2411 11620 The tailing factor should be NMT 2.0 1.50 1.10 The RSD of five replicate injection should be NMT 2.0% 0.42 0.90
Specificity
Peak of Aminexil and Minoxidil should be pure Peaks of Aminexil and Minoxidil are pure. The degradation products should be well resolved from Aminexil and Minoxidil peaks All Impurity degradation products were well separated from Aminexil and Minoxidil peak and each other. Peak purity criteria for Aminexil and Minoxidil should be pass in all stress testing conditions Pass Pass
System precision The RSD of the Retention …show more content…
For the sample, the area difference of Aminexil and Minoxidil peak should be within ± 2.0%.
Sample is stable up to 24 hours at room temperature. …show more content…
The developed method consisting the mobile phase 3g of Docusate Sodium was dissolved in 580 ml of Methanol, sonicated to dissolve to this 420 mL of milli Q water was added and pH was adjusted at 3.0 with perchloric acid with isocratic programming, XTerra RP 18 column (250mm×4.6mm, 5μm) column as stationary phase with a flow rate of 1.0 ml/minute. Proposed method was found to be linear in the concentration range of 18.80 to 56.60 µg/mL for Aminexil and 25.00 to 75.20 µg/mL for Minoxidil respectively, the correlation coefficient was found to be 0.999. Precision study showed that the percentage relative standard deviation was within the range of acceptable limits, and the mean recovery was found to be 101.30 % for Aminexil and 101.10% for Minoxidil. The developed method was validated for specificity by stress studies. Minoxidil and Aminexil were subjected to stress condition and products were analyzed by using photo diode array detector. It was found to be stable in milder condition of stress (0.01 N HCl, 0.01 N NaOH, 1% H2O2, at room temperature for one hour 9 hours). The analyte peaks were well resolved from the degraded
Validation parameters Acceptance criteria Results Aminexil Minoxidil
System suitability Theoretical plates should be NLT 2000 2411 11620 The tailing factor should be NMT 2.0 1.50 1.10 The RSD of five replicate injection should be NMT 2.0% 0.42 0.90
Specificity
Peak of Aminexil and Minoxidil should be pure Peaks of Aminexil and Minoxidil are pure. The degradation products should be well resolved from Aminexil and Minoxidil peaks All Impurity degradation products were well separated from Aminexil and Minoxidil peak and each other. Peak purity criteria for Aminexil and Minoxidil should be pass in all stress testing conditions Pass Pass
System precision The RSD of the Retention …show more content…
For the sample, the area difference of Aminexil and Minoxidil peak should be within ± 2.0%.
Sample is stable up to 24 hours at room temperature. …show more content…
The developed method consisting the mobile phase 3g of Docusate Sodium was dissolved in 580 ml of Methanol, sonicated to dissolve to this 420 mL of milli Q water was added and pH was adjusted at 3.0 with perchloric acid with isocratic programming, XTerra RP 18 column (250mm×4.6mm, 5μm) column as stationary phase with a flow rate of 1.0 ml/minute. Proposed method was found to be linear in the concentration range of 18.80 to 56.60 µg/mL for Aminexil and 25.00 to 75.20 µg/mL for Minoxidil respectively, the correlation coefficient was found to be 0.999. Precision study showed that the percentage relative standard deviation was within the range of acceptable limits, and the mean recovery was found to be 101.30 % for Aminexil and 101.10% for Minoxidil. The developed method was validated for specificity by stress studies. Minoxidil and Aminexil were subjected to stress condition and products were analyzed by using photo diode array detector. It was found to be stable in milder condition of stress (0.01 N HCl, 0.01 N NaOH, 1% H2O2, at room temperature for one hour 9 hours). The analyte peaks were well resolved from the degraded