method validation of Albendazole

UV Spectroscopic assay method Validation of
Albendazole in three different brand tablet
formulations used in Bangladesh.
Presented by
Al Imran (B.Pharm)
Department of Pharmacy
Dhaka International University

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

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.

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.

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

Method validation
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY VALIDATION PARAMETERS

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.

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.

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.

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

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
Alba
0.999
0.9998
Estazol 0.9997
0.9997Almex
2 Accuracy
Standard
% RSD <2%
0.0116
Alba 0.0092
Estazol 0.8456
Almex 0.1531

result
3 Precision
Repeatability
Standard 2.3904
Alba 2.2797
Estazol 2.7469
Almex 2.2573
Intraday
Standard 1.1108
0.5154
Alba
2.4551Estazol
Almex 1.2051
Inter day
Standard 1.2839
Alba 0.4876
Estazol 0.3933
Almex 0.8131

result
4 LOD
Alba 0.5746 µg/ml
Estazol 0.591 µg/ml
Almex 0.5838 µg/ml
5 LOQ
Alba 1.7412 µg/ml
Estazol 1.791 µg/ml
Almex 1.7693 µg/ml
6
Robustness (%
RSD)
Alba
% Assay
127.4
121.8Estazol
Almex 111.6

Comparison of validation parameters
Linearity and Accuracy
0.9998 0.9997 0.9997
0.0116 0.0092
0.8456
0.1531
0
0.2
0.4
0.6
0.8
1
1.2
Standard Alba Estazol Almex
Linearity
Accuracy

Repeatability; Intraday and Interday
2.3904 2.2797
2.7469
2.2573
1.1108
0.5154
2.4551
1.20511.2839
0.48 0.39
5
0
1
2
3
4
5
6
Standard Alba Estazol Almex
Repeatability
Intraday
Interday

LOD & LOQ
0.57 0.59 0.58
1.74 1.79 1.76
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
Alba Estazol Almex
LOD
LOQ

robustness
127.4
121.8
111.6
100
105
110
115
120
125
130
Alba Estazol Almex
Robustness
Robustness

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

Comparison of physical parameter
Ave. Weight (gm.)
0.94
0.65
0.75
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Alba Estazol Almex
ave. weight (gm)
ave. weight (gm)

Weight variation (gm.) %
0.012
0.042
0.26
0
0.05
0.1
0.15
0.2
0.25
0.3
Alba Estazol Almex
Weight variation
Weight variation

Friability %
0.1
0.3
0.26
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
Alba Estazol Almex
Friability %

Ave. hardness (kg.cm2)
5.7
4.8
6.3
0
1
2
3
4
5
6
7
Alba Estazol Almex
Ave. Hardness
Ave. Hardness

Discussion
The proposed method for estimation of Albendazole dosage form was found to be accurate,
simple and rapid without repeatability precision parameter. The 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.

conclusion
The reagents utilized in the proposed method are cheap, readily available, and quite stable in solution unlike
many reagents. 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.

references
 Davidson AG (2002) Ultraviolet-visible absorption spectrophotometry. In BeckettAH, Stenlake JB, (4thedn), Practical
Pharmaceutical chemistry. CBS Publishers and distributors, New Delhi, 275-278.
 CITAC/EURACHEM, Working Group, International guide to quality in analytical chemistry: An aid to accreditation, 2002.
 International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for
Human Use, Validation of analytical procedures: Methodology, adopted in 1996, Geneva
 SPECTROPHOTOMETRIC DETERMINATION OF ALBENDAZOLE IN PURE FORM AND TABLET FORM, Mohamed M. Baraka et al.
/ Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2(4), 2014, 276-294.
 WHO Model List of Essential Medicines" (PDF). World Health Organization. October 2013. Retrieved 22 April 2014.
 Neonatal Formulary: Drug Use in Pregnancy and the First Year of Life. John Wiley & Sons. 2014. p. 64. ISBN
9781118819593.
 International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for
Human Use, Validation of analytical procedures: definitions and terminology, Geneva (1996)
 Guideline on general principles of process validation". U.S. Food and Drug Administration. Archived from the original on 6
June 2009. Retrieved 12 July 2008.
 Validation definition and FDA, Regulatory agencies guidelines requirement. Accessed 27 Feb 2014.
 DEVELOPMENT AND VALIDATED UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ALBENDAZOLE IN TABLET
DOSAGE FORM, Sandhya Bhimrao Lahane, Dr.U.A.Deokate, World Journal of Pharmaceutical Research, Volume 3, Issue 4,
1461-1467

method validation of Albendazole

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method validation of Albendazole