pressurized salbutamol inhalation
TRANSCRIPT
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Ventolin®Ventolin®
Salbutamol SulphateSalbutamol SulphateSalbutamol SulphateSalbutamol Sulphate
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ContentsContents
Objective
General Information
Quality control
Conclusion and Discussion
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ObjectiveObjective
เพื่��อศึ�กษาการตรวจสอบคุ�ณภาพื่ของยาในร�ปแบบ Inhalers
เพื่��อศึ�กษาการประย�กต�ว�ธี!การว�เคุราะห์� ให์#เห์มาะสมก%บเคุร��องม�อ และสารเคุม!ที่!�ม!อย�(
General Information
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Ventolin®Ventolin®
Active ingredients : Salbutamol 100 micrograms per actuation
Pharmaceutical form: Pressurised Inhalation, solutions
Action and use :Selective beta-2 adrenoceptor agonist,
Bronchodilator
Quality control
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Salbutamol Pressurised InhalationSalbutamol Pressurised Inhalation
Identification
Tests related substances
Salbutamol ketone
ASSAY
Salbutamol Pressurised InhalationSalbutamol Pressurised Inhalation
ว�ธี!ว�เคุราะห์� : HPLC
Mobile phase :
0.1%w/v ammonium acetate : Methanol (20:80)
Column : C-18 ความยาว 20 เซนติ�เมติร
AssayAssay
สารเคุม!สารเคุม! Standard Salbutamol BP Ammonium acetate Methanol HPLC grade Water (DI)
เคุร��องม�อและอ�ปกรณ�ที่!�ใช้#เคุร��องม�อและอ�ปกรณ�ที่!�ใช้# เคร �องHPLC Beaker 50, 100, 250, 1000 ml Cylinder 50, 100 ml Volumetric flask 50, 250 ml Funnel Watch glass ขวดmobile phase Dropper Transfer pipet 10, 25 ml
Stock solution : standard salbutamol 0.5 mg/ml in mobile phase
salbutamol sulphate 125 mg 50 ml(2.5mg/ml)
pipet 10 ml 50 ml(0.5 mg/ml)
ว�ธี!การเตร!ยม standard ว�ธี!การเตร!ยม standard
standard salbutamol 0.02mg/ml in mobile phase Pipet stock solution 2 ml 50 ml (0.02mg/ml)
standard salbutamol 0.015mg/ml in mobile phase Pipet stock solution 1.5 ml 50 ml(0.015mg/ml)
standard salbutamol 0.01mg/ml in mobile phase Pipet stock solution 1 ml 50 ml (0.01mg/ml)
standard salbutamol 0.005mg/ml in mobile phase Pipet stock solution 0.5 ml 50 ml (0.005mg/ml)
ว�ธี!การเตร!ยม standard ว�ธี!การเตร!ยม standard
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Step 1Step 1 Step 2Step 2 Step 3Step 3
ผสมMethanol 44ml
น,-า 44 ml0.1% w/v ammonium
acetate 56 ml
ผสมMethanol 44ml
น,-า 44 ml0.1% w/v ammonium
acetate 56 ml
ว�ธี!การเตร!ยม sampleว�ธี!การเตร!ยม sample
แล้�วปร�บปร�มาติร ด�วยน��าจนครบ
250 ml ในvolumetric flask
แล้�วปร�บปร�มาติร ด�วยน��าจนครบ
250 ml ในvolumetric flask
พ่�นยาล้งไป 25 คร��ง
พ่�นยาล้งไป 25 คร��ง
Carry out sampleCarry out sample
Carry out sampleCarry out sample
System suitabilitySystem suitability
Tailing factor : 1.83 Plate number : 2,531.17 k’ : 1.02 Resolution : N/A Separation factor : N/A % RSD : 1.534
Conclusion and Discussion
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ConclusionConclusion
salbutamolmg/ml
potency 99.24% time Area
Average area
0.0050.005 4.29
4.293898039644
39312
0.0100.010 4.30
4.297902978568
78798.5
0.0150.015 4.29
4.29115431120507
117969
0.0200.020 4.29
4.29152328151541
151934.5
ConclusionConclusion
Calibration curve of standard salbutamol
39312
78798.5
117969
151934.5
y = 7540760x + 2744
R2 = 0.9988
0
20000
40000
60000
80000
100000
120000
140000
160000
180000
0 0.005 0.01 0.015 0.02 0.025
Concentration (mg/mL)
Pea
k ar
ea
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Time AreaAverage
area
Sample I4.314.31
244278247082
245680
Sample II4.314.31
217782218240
218011
Sample III4.314.30
130231123559
126895
Sample IV4.304.30
8606688378
87222
ConclusionConclusion
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Area Average area mg/mL mg/puff mcg/mL mcg/puff
Sample I134532134759
134645.5 0.017 0.175 17 175
Sample II9737096083
96726.5 0.012 0.125 12 125
Sample III
121913124873
123393 0.016 0.160 16 160
ConclusionConclusion
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Tailing FactorTailing Factor
T = Tailing factor (measured at 5% of peak height)b = Distance from the point at peak midpoint to the trailing edge a = Distance from the leading edge of the peak to the midpoint
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number of Theoretical Platesnumber of Theoretical Plates
N = Number of theoretical platesVe = Elution volume or retention time (mL, sec, or cm)h = Peak heightw1/2 = Width of the peak at half peak height (mL, sec, or cm)
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Number of Theoretical Plates (USP method)Number of Theoretical Plates (USP method)
N = Number of theoretical platesVe = Elution volume, retention time or retention distance (mL, sec, or cm)h = Peak height wb = Width of the peak at the base line (mL, sec, or cm)
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Capacity factor (k’)Capacity factor (k’)
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Chromatographic resolutionChromatographic resolution
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Separation factor (Relative retention)Separation factor (Relative retention)
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Relative standard deviation (%RSD)Relative standard deviation (%RSD)
%RSD = (SD/Mean of Peak area) X 100 - if a relative standard deviation of <2% is required then five replicate injections should be used - if a relative standard deviation of >2% is required then six replicate injections should be used