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

Presented by

Al ImranRoll: 27

Batch: 13th Session: 2012-2013

Department of PharmacyDhaka International University

Content

1. Introduction2. Objective 3. Method validation4. Drug profile5. Method and Materials6. Result7. Discussion8. Conclusion

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 validationVALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY VALIDATION PARAMETERS

1- Accuracy

2- Precisiona- Intermediate Precision b- Repeatability

3- Specificity

4- Limit of detection

Method validationVALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY VALIDATION PARAMETERS

5- Limit of Quantitation

6- Linearity7- Range

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 albendazoleMechanism of ActionAlbendazole 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

DosageA 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 effectsAlbendazole may cause abdominal painDizzinessHeadachefever, nauseaVomiting or temporary hair loss.

Drug profile albendazoleDrug 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.

ContraindicationsHypersensitivityLiver disease Pregnancy & lactationChildren less than two years

result

λ max: 308 nmSolvent: Ethanolic HClMachine: Single cell UV-vis spectroscopy (Shimadzu)Sample 01: Alba, Navana PharmaSample 02: Estazol, Ibn Sina PharmaSample 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

result

3 Precision

 

Repeatability

Standard 2.3904Sample 1 2.2797

Sample 2 2.7469

Sample 3 2.2573

 

Intraday

Standard 1.1108

0.5154Sample 1

2.4551

Sample 2

Sample 3 1.2051

 

Inter day

Standard 1.2839

Sample 1 0.4876

Sample 2 0.3933

Sample 3 0.8131

 

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

6Robustness (% RSD)

Sample 1

% Assay

127.4

121.8

Sample 2

Sample 3 111.6

resultComparison 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

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.

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.

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