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Validation of HPLC method for
determination of Atorvastatin
Presented by
KOMAL AROOSH
Roll no :- S2019140032
Session:- 2019-2021
DEPARTMENT OF CHEMISTRY
UNIVERSITY OF MANAGEMENT AND TECHNOLOGY
LAHORE
IN THE NAME OF ALLAH, THE
BENIFICIENT THE MERCIFUL
Contents
• Introduction(Atorvastatin)
• Drug Activity
• Side Effects
• Comparison of the Results
• Conclusion
• References
Atorvastatin
INTRODUCTION
Generic name:- Atorvastatin
Chemical name:- (3R,5R)-7-[2-(4-flouorophenyl)-3-phenyl-4-
(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]3,5-
dihydroxyheptanoic acid
• It is a member of drug called statin.
• Primarily used in
 lowering blood cholesterol
 prevention of events associated with cardiovascular
disease.
• It works by inhibiting HMG-CoA reductase, an enzyme found
in liver tissue that plays a key role in production of cholesterol
in the body.
• Rapid absorption when taken orally.
• The liver is the primary site of action of atorvastatin.
• Decreases the LDL level.
• Decreases triglycerides.
Drug Activity
Dosage
It comes in tablets (White or
Yellow in color) and capsule
form. –
Initial dose: 10 mg or 20 mg
orally once a day; an initial
dose of 40 mg may be used in
patients who require a
reduction in low density
lipoprotein (LDL-C) of more
than 45%
Maintenance dose: 10 mg to
80 mg orally once a day
Side Effects
• Rhabdomolysis
• Memory problem
• Fever
• Dizziness
• Loss of appetite
• Yellowing of the skin and eyes.
Comparison of the Results
Paper 1(µg/ml) Paper 2(µg/ml) Paper 3(µg/ml)
0.071 0.189 35
Limit Of Detection
(LOD)
0
5
10
15
20
25
30
35
Paper 1 Paper 2 Paper 3
LOD
LimitofDetection(µg/ml)
Paper 1 shows the lowest concentration
while Paper 3 shows highest
concentration.
Paper 1(µg/ml) Paper 2(µg/ml) Paper 3(µg/ml)
0.0356 0.603 15
Limit Of Quantification
(LOQ)
Comparison of the Results
0
2
4
6
8
10
12
14
16
Paper 1 Paper 2 Paper 3
LOQ
LimitofQuantification(µg/ml)
Paper 1 shows the lowest concentration
while Paper 3 shows highest
concentration.
Paper 1 Paper 2 Paper 3
4.5 min 1.82 min 6.5 min
Comparison of the Results
Retention Time Retention Time
Paper 1 Paper 2 Paper 3
6.5 min 4.5 min
1.5 min
Paper 2 shows the lowest retention time
while Paper 3 shows highest retention
time.
Comparison of the Results
Linearity
In all the papers , the values obtained were
showing good linearity.
Paper 1 Paper 2 Paper 3
0.9995 0.999 >0.999
Correlation Coefficient
Comparison of the Results
The vale of correlation coefficient was also almost same in all the papers.
Paper 1 Paper 2 Paper 3
99.50 % 100 % 100 %
Recovery %age
Comparison of the Results
All the papers were showing almost 100 % recovery
According to all results comparison we get that:-
Paper 1 gives
i. validated
ii. specific
iii. linear
iv. precise
v. accurate
Results.
Conclusion
References
• Mallesh K, Tariq R S , El-Helw AM, Magdy YA(2014)Development and Validation of a RP-
HPLC Method for Assay of Atorvastatin and its Application in Dissolution Studies on
Thermo sensitive Hydrogel-Based Nanocrystals. Tropical Journal of Pharmaceutical
Research 13: 1681-1687
• Hassan A A, Ahmad M A ,Mohammed A.A A, Raad K.A, Mohammad A B Zia ur R,
Sadique A. J, Ismail A. A (2018)A Fast and Validated Reversed-Phase HPLC Method for
simultaneous Determination of Simvastatin,Astorvastatin,Telmisartan and Irbesartan in
Bulk Drugs and Tablet Formulation. Sci Pharm86:1
• Beata S, Lukasz K(2006) Validation of HPLC Method for Determination of Atorvastatin in
Tablets and for Monitoring Stability in Sold Phase. Acta Poloniae Pharmaceutica-Drug
Research 63: 471-476

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Validation of HPLC method for determination of atorvastatin

  • 1. Validation of HPLC method for determination of Atorvastatin Presented by KOMAL AROOSH Roll no :- S2019140032 Session:- 2019-2021 DEPARTMENT OF CHEMISTRY UNIVERSITY OF MANAGEMENT AND TECHNOLOGY LAHORE IN THE NAME OF ALLAH, THE BENIFICIENT THE MERCIFUL
  • 2. Contents • Introduction(Atorvastatin) • Drug Activity • Side Effects • Comparison of the Results • Conclusion • References
  • 3. Atorvastatin INTRODUCTION Generic name:- Atorvastatin Chemical name:- (3R,5R)-7-[2-(4-flouorophenyl)-3-phenyl-4- (phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]3,5- dihydroxyheptanoic acid • It is a member of drug called statin. • Primarily used in  lowering blood cholesterol  prevention of events associated with cardiovascular disease. • It works by inhibiting HMG-CoA reductase, an enzyme found in liver tissue that plays a key role in production of cholesterol in the body.
  • 4. • Rapid absorption when taken orally. • The liver is the primary site of action of atorvastatin. • Decreases the LDL level. • Decreases triglycerides. Drug Activity Dosage It comes in tablets (White or Yellow in color) and capsule form. – Initial dose: 10 mg or 20 mg orally once a day; an initial dose of 40 mg may be used in patients who require a reduction in low density lipoprotein (LDL-C) of more than 45% Maintenance dose: 10 mg to 80 mg orally once a day
  • 5. Side Effects • Rhabdomolysis • Memory problem • Fever • Dizziness • Loss of appetite • Yellowing of the skin and eyes.
  • 6. Comparison of the Results Paper 1(µg/ml) Paper 2(µg/ml) Paper 3(µg/ml) 0.071 0.189 35 Limit Of Detection (LOD) 0 5 10 15 20 25 30 35 Paper 1 Paper 2 Paper 3 LOD LimitofDetection(µg/ml) Paper 1 shows the lowest concentration while Paper 3 shows highest concentration.
  • 7. Paper 1(µg/ml) Paper 2(µg/ml) Paper 3(µg/ml) 0.0356 0.603 15 Limit Of Quantification (LOQ) Comparison of the Results 0 2 4 6 8 10 12 14 16 Paper 1 Paper 2 Paper 3 LOQ LimitofQuantification(µg/ml) Paper 1 shows the lowest concentration while Paper 3 shows highest concentration.
  • 8. Paper 1 Paper 2 Paper 3 4.5 min 1.82 min 6.5 min Comparison of the Results Retention Time Retention Time Paper 1 Paper 2 Paper 3 6.5 min 4.5 min 1.5 min Paper 2 shows the lowest retention time while Paper 3 shows highest retention time.
  • 9. Comparison of the Results Linearity In all the papers , the values obtained were showing good linearity.
  • 10. Paper 1 Paper 2 Paper 3 0.9995 0.999 >0.999 Correlation Coefficient Comparison of the Results The vale of correlation coefficient was also almost same in all the papers.
  • 11. Paper 1 Paper 2 Paper 3 99.50 % 100 % 100 % Recovery %age Comparison of the Results All the papers were showing almost 100 % recovery
  • 12. According to all results comparison we get that:- Paper 1 gives i. validated ii. specific iii. linear iv. precise v. accurate Results. Conclusion
  • 13. References • Mallesh K, Tariq R S , El-Helw AM, Magdy YA(2014)Development and Validation of a RP- HPLC Method for Assay of Atorvastatin and its Application in Dissolution Studies on Thermo sensitive Hydrogel-Based Nanocrystals. Tropical Journal of Pharmaceutical Research 13: 1681-1687 • Hassan A A, Ahmad M A ,Mohammed A.A A, Raad K.A, Mohammad A B Zia ur R, Sadique A. J, Ismail A. A (2018)A Fast and Validated Reversed-Phase HPLC Method for simultaneous Determination of Simvastatin,Astorvastatin,Telmisartan and Irbesartan in Bulk Drugs and Tablet Formulation. Sci Pharm86:1 • Beata S, Lukasz K(2006) Validation of HPLC Method for Determination of Atorvastatin in Tablets and for Monitoring Stability in Sold Phase. Acta Poloniae Pharmaceutica-Drug Research 63: 471-476