Identification,Ultraviolet Absorption á197Uñ
Solution
Dilute a quantity of Suspension with a mixture of methanol and hydrochloric acid (99:1)to obtain a solution having a concentration of about 1mg per mL.Filter the mixture,if necessary,to obtain a clear solution.Transfer 1mLof this solution to a 100-mLvolumetric flask,dilute with 0.1Nsodium hydroxide to volume,and mix.
Assay
Acidified methanol
Use a mixture of methanol and hydrochloric acid (99:1).
Mobile phase
Dissolve 11.0g of monobasic sodium phosphate in 800mLof water.Add 1200mLof methanol,and mix.Make adjustments if necessary (see
System Suitabilityunder
Chromatography á621ñ).
Standard preparation
Quantitatively dissolve an accurately weighed quantity of
USP Albendazole RSin
Acidified methanolto obtain a stock solution having a known concentration of about 1mg per mL.Dilute an accurately measured volume of this stock solution with
Mobile phaseto obtain a solution having a known concentration of about 100µg per mL.
Assay preparation
Transfer an accurately measured volume of Oral Suspension,equivalent to about 100mg of albendazole,to a 100-mLvolumetric flask,dilute with Acidified methanolto volume,and mix.Transfer 10.0mLof this solution to a second 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Filter,if necessary,to obtain a clear solution.
Chromatographic system(see Chromatography á621ñ)
The liquid chromatograph is equipped with a 308-nm detector and a 4-mm ×25-cm column that contains packing L1.The flow rate is about 2mLper minute.Chromatograph the
Standard preparation,and record the peak responses as directed for
Procedure:the column efficiency is not less than 2000theoretical plates;the tailing factor is not more than 2.0;and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure
Separately inject equal volumes (about 20µL)of the
Standard preparationand the
Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of albendazole (C
12H
15N
3O
2S)in each mLof the Oral Suspension taken by the formula:
(C/V)(rU/rS),
in which
Cis the concentration,in µg per mL,of
USP Albendazole RSin the
Standard preparation;and
rUand
rSare the albendazole peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.