UV Spectroscopic assay method development and Validation of Albendazole in three different brand tablet formulations used in Bangladesh.

1. UV Spectroscopic assay method development
and Validation of Albendazole in three different
brand tablet formulations used in Bangladesh.
Presented by
Al Imran
Roll: 27
Batch: 13th
Session: 2012-2013
Department of Pharmacy
Dhaka International University

2. Content
1. Introduction
2. Objective
3. Method validation
4. Drug profile
5. Method and Materials
6. Result
7. Discussion
8. Conclusion

3. Introduction
In most general sense, a drug may be defined as any substance that brings about a
change in biological function through its chemical actions. A drug is any substance
other than food, that when inhaled, injected, smoked, consumed, absorbed via a
patch on the skin or dissolved under the tongue causes a physiological change in the
body.
Medicine is a drug that can help people if the amount of medicine is right. People
take medicine because they want to get better if they have illness they want to feel
relieved of their pain even for temporary.

4. Objective
Numerous novel drugs are being introduced and are constantly growing
day by day. Therefore it is absolutely imperative to evolve novel
methods and introduced them for controlling their quality. The
objective of the study is the UV Spectroscopic assay method
development and Validation of Albendazole in three different brand
tablet formulations used in Bangladesh.

5. Method Validation
Method validation is the process used to confirm that the analytical procedure employed
for a specific test is suitable for its intended use. Results from method validation can be
used to judge the quality, reliability and consistency of analytical results; it is an integral
part of any good analytical practice.
Why Method Validation is Important?
1.The purpose of analytical measurement is to get consistent, reliable and accurate data.
Incorrect measurement results can lead to tremendous costs.
2. Equal importance for those working in a regulated and in an accredited environment.
U.S. FDA, EMEA, EPA, AOAC, ISO

6. Method validation
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY VALIDATION PARAMETERS

7. Method validation
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY VALIDATION PARAMETERS

8. Drug Profile ALBEndazole
Albendazole (methyl N-(6-propylsulfanyl-1H-benzimidazol-2-yl) carbamate)
marketed as Albenza among others, is a medication used for the treatment of a variety of
parasitic worm infestations. It is useful for giardiasis, trichuriasis, filariasis,
neurocysticercosis, hydatid disease, pinworm disease, and ascariasis, among others. It is
taken by mouth. Albendazole developed in 1975. It is on the World Health
Organization's List of Essential Medicines, the most important medications needed in a
basic health system.

9. Drug profile
albendazole
Mechanism of Action
Albendazole binds to the colchicine-sensitive site of β-tubulin inhibiting their
polymerization into microtubules. The decrease in microtubules in the intestinal
cells of the parasites decreases their absorptive function, especially the uptake of
glucose by the adult and larval forms of the parasites, and also depletes glycogen
storage. Insufficient glucose results in insufficient energy for the production of
adenosine triphosphate (ATP) and the parasite eventually dies.

10. Drug profile
albendazole
Dosage
A single dose of 400 mg is recommended for clearance of gastrointestinal nematode
infection of both adults and children over 2 years of age. Additional or more
frequent dosage may be advised in certain conditions, including systemic disease.
Side effects
Albendazole may cause
abdominal pain
Dizziness
Headache
fever, nausea
Vomiting or
temporary hair loss.

11. Drug profile
albendazole
Drug Interactions
Taking albendazole with a fatty meal increases its absorption by two to six- folds.
The concentration of albendazole sulphoxide in blood is increased by 50% when
administered concurrently with dexamethasone and by 4.5 fold when administered
concurrently with praziquantel. Administration of albendazole with grapefruit juice
results in a 3-fold increase in Cmax of albendazole sulphoxide.
Contraindications
Hypersensitivity
Liver disease
Pregnancy & lactation
Children less than two years

12. result
λ max: 308 nm
Solvent: Ethanolic HCl
Machine: Single cell UV-vis
spectroscopy (Shimadzu)
Sample 01: Alba, Navana Pharma
Sample 02: Estazol, Ibn Sina
Pharma
Sample 03: Almex, Square Pharma
Sl no. Parameters Normal Range Result
1 Linearity
Sample 1
0.999
0.9998
Sample 2 0.9997
0.9997Sample 3
2 Accuracy
Standard
% RSD <2%
0.0116
Sample 1 0.0092
Sample 2 0.8456
Sample 3 0.1531

13. result
3 Precision
Repeatability
Standard 2.3904
Sample 1 2.2797
Sample 2 2.7469
Sample 3 2.2573
Intraday
Standard 1.1108
0.5154
Sample 1
2.4551Sample 2
Sample 3 1.2051
Inter day
Standard 1.2839
Sample 1 0.4876
Sample 2 0.3933
Sample 3 0.8131

14. result
4 LOD
Sample 1 0.5746 µg/ml
Sample 2 0.591 µg/ml
Sample 3 0.5838 µg/ml
5 LOQ
Sample 1 1.7412 µg/ml
Sample2 1.791 µg/ml
Sample 3 1.7693 µg/ml
6
Robustness (%
RSD)
Sample 1
% Assay
127.4
121.8Sample 2
Sample 3 111.6

15. result
Comparison of physical parameter of his three brands.
Name Ave . Weight (gm.) Weight variation
(gm.) %
Friability
%
Ave. hardness
(kg.cm2)
Alba 0.946 0.012 0.1057 5.74
Estazol 0.656 0.042 0.3048 4.81
Almex 0.752 0.092 0.2659 6.31

16. Discussion
The proposed method for estimation of Albendazole dosage form was found to be accurate,
simple and rapid without intraday precision parameter. The calibration and assay results were
shown in above table. The % RSD of accuracy, intraday, interday, LOD and LOQ is found to
be less than 2, which indicates the validity of method. But repeatability result are not
follows ICH guidelines; this cause may be environment effect, solvent effect or are not
qualified sterility of apparatus.
Linearity was observed by regression equation for Albendazole in different concentration
range. The assay results obtained by proposed method were precise; hence it can be used for
routine analysis of Albendazole dosage form. The method is accurate, simple, rapid, precise,
reliable, sensitive, reproducible and economic and is validated as per ICH guidelines.

17. conclusion
The reagents utilized in the proposed method are cheap, readily available, and quite stable in solution unlike
many reagents used in above reported method. The procedures do not involve any critical reaction conditions
such as rigid pH control, tedious and time-consuming extraction or heating step. The methods are more
sensitive than many of the reported spectrophotometric methods and applicable over wide linear dynamic
ranges. The methods are free from interferences from the common excipients. The statistical parameters and
the recovery data reveal good accuracy and precision of the methods. The methods have many other
advantages such as reduced cost, simplicity, and speed. Hence, the methods can be used in routine analysis
of the drug in quality control laboratories and pharmaceutical analysis.

18. Thank you