QUALITY CONTROL

Document code: Issue status: Effective date:

Page 1 of 2
QP/QC/02/WI-A050 01 10-07-2007
DOCUMENT TITLE:
STANDARD ANALYTICAL PROCEDURE
FOR
ALBENDAZOLE

PURPOSE & SCOPE:

It is established for chemical analysis of ALBENDAZOLE is applicable to Quality Control department.

RESPONSIBILITY:
1. Manager Quality Control.
2. Assistant Manager Quality Control.
3. Quality Control Analyst.

DESCRIPTION:
Appearance: A white or faintly yellowish powder (BP)
Solubility: Practically insoluble in water, freely soluble in anhydrous formic acid. Very slightly soluble in methylene chloride,
practically insoluble in alcohol (BP)

C12H15N3O2S 151.2

IDENTIFICATION:
1) Prepare sample and standard solutions as per procedure given under UV method. The absorption spectrum of sample
solution is similar to that of standard solution.

TESTS:
Loss on drying: Not more than 0.5 per cent, determined on 1.000 g by drying in an oven at 100°C to 105°C for 4 hours (BP 2007)

ASSAY:
Assay: Weigh accurately about 250mg, dissolve in 40 ml of anhydrous glacial acetic acid and carry out non-aqueous titration, using
crystal violet solution as indicator. Perform a blank determination and make any necessary correction. Each ml of 0.1M perchloric acid
is equivalent to 26.53 mg of C12H15N3O2S. (IP 1996)

Assay: Dissolve about 0.25 g, accurately weighed, in 3ml of anhydrous formic acid R, and add 40 ml of glacial acetic acid R1. Then
add 0.2 ml of 1-naphtholbenzein/acetic acid TS and titrate with 0.1M perchloric acid VS until a green colour is obtained (International
Pharmacopoeia)

Prepared by: Reviewed by: Approved by:

 QUALITY CONTROL
Document code: Issue status: Effective date:
Page 2 of 2
QP/QC/02/WI-A050 01 10-07-2007
DOCUMENT TITLE:
STANDARD ANALYTICAL PROCEDURE
FOR
ALBENDAZOLE

UV method:
Sample solution: Dissolve 100 mg of Albendazole sample in glacial acetic acid and dilute to 100ml with the same reagent. Filter, if
necessary, and dilute 2 ml of the filtrate to 100 ml with water.
Standard solution: Dissolve 100 mg of Albendazole standard in glacial acetic acid and dilute to 100ml with the same reagent. Filter,
if necessary, and dilute 2 ml of the filtrate to 100 ml with water.
Measure the absorbance of both sample and reference solutions and deduce the result by comparison.
Final concentration of Sample and Reference solution: 0.02 mg/ml.
Wavelength (lmax): 298 nm.
Blank: add 1ml of glacial acetic acid to 50ml volumetric flask and dilute to 50ml with water.

Limit: 98 ~ 102 % (USP24/BP2007)

RELATED DOCUMENTS
S.No Document Title Document Code S.No Document Title Document Code
Request for Sampling of Raw Q.C Analysis Certificate for Raw
1 QF/STR/001 4 QF/QC/003
Material. Material.
2 Raw Material Entry Register QF/QC/006 5 “Approved Raw Material” slip QF/QC/009
3 Analysis Record for Raw Materials QF/QC/017 6 “Rejected Raw Material” slip QF/QC/011

Prepared by: Reviewed by: Approved by: