This is a presentation about the Validation of the HPLC method for the determination of Atorvastatin. Here I discussed what is atorvastatin, its side effects, drug activity, and dosage that humans can intake. then a comparison of the results of five papers is discussed while concluding the result with the best method...
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
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
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