Haloperidol Oral Solution
»Haloperidol Oral Solution is a solution of Haloperidol in Water,prepared with the aid of Lactic Acid.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of haloperidol (C21H23ClFNO2).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— The solution prepared for measurement of absorbance in the Assayexhibits a maximum at 245±2nm.
Uniformity of dosage units á905ñ
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pHá791ñ: between 2.75and 3.75.
Assay— Transfer an accurately measured volume of Oral Solution,equivalent to about 10mg of haloperidol,to a separator,and add 20mLof dilute hydrochloric acid (1in 20).Extract the solution with four 20-mLportions of ether,and wash the combined ether extracts with four 5-mLportions of dilute hydrochloric acid (1in 20).Discard the ether,and add the acid washings to the aqueous phase.Filter the aqueous phase through a pledget of cotton into a 50-mLvolumetric flask,add dilute hydrochloric acid (1in 20)to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with methanol to volume,and mix.Concomitantly determine the absorbances of this solution and of a solution of USP Haloperidol RSin the same medium having a known concentration of about 20µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 245nm,with a suitable spectrophotometer,using a 1in 10solution of dilute hydrochloric acid (1in 20)in methanol as the blank.Calculate the quantity,in mg,of haloperidol (C21H23ClFNO2)in each mLof Oral Solution taken by the formula:
0.5(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Haloperidol RSin the Standard solution;Vis the volume,in mL,of Oral Solution taken;and AUand ASare the absorbances of the solution from the Oral Solution and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 938
Pharmacopeial Forum:Volume No.29(6)Page 1897
Phone Number:1-301-816-8330