Amodiaquine Hydrochloride Tablets
»Amodiaquine Hydrochloride Tablets contain an amount of amodiaquine hydrochloride (C20H22ClN3O·2HCl·2H2O)equivalent to not less than 93.0percent and not more than 107.0percent of the labeled amount of amodiaquine (C20H22ClN3O).
Packaging and storage— Preserve in tight containers.
Identification—
A: Infrared Absorption á197Kñ—Prepare the test specimen as follows.Powder 1or more Tablets,and transfer a portion of the powder,equivalent to about 50mg of amodiaquine,to a 125-mLseparator.Add 20mLof water,and shake for 1minute.Add 25mLof chloroform and 1mLof ammonium hydroxide,shake for 2minutes,and when settled,filter the chloroform extract through cotton that previously has been rinsed with chloroform,collecting the extract in a vessel suitable for evaporation.Evaporate the chloroform,and dry the residue at 105for 1hour.
B: Ultraviolet Absorption á197Uñ—
Solution: prepared as directed in the Assay.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 30minutes.
Procedure— Determine the amount of C20H22ClN3O·2HCl·2H2Odissolved from UVabsorbances at the wavelength of maximum absorbance at about 342nm on filtered portions of the solution under test,suitably diluted with water,if necessary,in comparison with a Standard solution having a known concentration of USP Amodiaquine Hydrochloride RSin the same medium.
Tolerances— An amount of amodiaquine hydrochloride (C20H22ClN3O·2HCl·2H2O)equivalent to not less than 75%(Q)of the labeled amount of amodiaquine (C20H22ClN3O)is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 300mg of amodiaquine,to a 250-mLbeaker,add about 100mLof dilute hydrochloric acid (1in 100),and heat on a steam bath for about 15minutes with occasional stirring.Cool the mixture to room temperature,transfer to a 200-mLvolumetric flask,add dilute hydrochloric acid (1in 100)to volume,and mix.Pipet 10mLof the clear supernatant into a 125-mLseparator.Add about 10mLof dilute hydrochloric acid (1in 100),and wash with 20mLof chloroform,discarding the washing.Add 4.5mLof 1Nsodium hydroxide,and extract with four 25-mLportions of chloroform.Extract the combined chloroform solutions with three 50-mLportions of dilute hydrochloric acid (1in 100).Combine the acid extracts in a 200-mLvolumetric flask,add dilute hydrochloric acid (1in 100)to volume,and mix.Pipet 20mLof this solution into a 100-mLvolumetric flask,add dilute hydrochloric acid (1in 100)to volume,and mix.Concomitantly determine the absorbances of this solution and a solution of undried USP Amodiaquine Hydrochloride RS,in the same medium having a known concentration of about 15µg per mLin 1-cm cells at the wavelength of maximum absorbance at about 342nm,with a suitable spectrophotometer,using dilute hydrochloric acid (1in 100)as the blank.Calculate the quantity,in mg,of C20H22ClN3O·2HCl·2H2Oin the portion of Tablets taken by the formula:
21.68C(AU/AS),
in which Cis the concentration,in µg per mL,calculated on the anhydrous basis,of the USP Amodiaquine Hydrochloride RSin the Standard solution;and AUand ASare the absorbances of the solution from the Tablets and the Standard solution,respectively.The quantity determined,multiplied by 0.7656,gives the equivalent quantity of C20H22ClN3O.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 142
Phone Number:1-301-816-8394