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 90.0 percent and not more than 110.0 percent of the labeled amount of haloperidol (C21H23ClFNO2).
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification The solution prepared for measurement of absorbance in the Assay exhibits a maximum at 245 ± 2 nm.
Uniformity of dosage units 905
for oral solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral solution packaged in multiple-unit containers: meets the requirements.
pH 791: between 2.75 and 3.75.
Assay Transfer an accurately measured volume of Oral Solution, equivalent to about 10 mg of haloperidol, to a separator, and add 20 mL of dilute hydrochloric acid (1 in 20). Extract the solution with four 20-mL portions of ether, and wash the combined ether extracts with four 5-mL portions of dilute hydrochloric acid (1 in 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-mL volumetric flask, add dilute hydrochloric acid (1 in 20) to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Concomitantly determine the absorbances of this solution and of a solution of USP Haloperidol RS in the same medium having a known concentration of about 20 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 245 nm, with a suitable spectrophotometer, using a 1 in 10 solution of dilute hydrochloric acid (1 in 20) in methanol as the blank. Calculate the quantity, in mg, of haloperidol (C21H23ClFNO2) in each mL of Oral Solution taken by the formula:
0.5(C/V)(AU / AS)in which C is the concentration, in µg per mL, of USP Haloperidol RS in the Standard solution; V is the volume, in mL, of Oral Solution taken; and AU and AS are the absorbances of the solution from the Oral Solution and the Standard solution, respectively.
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USP35NF30 Page 3398Pharmacopeial Forum: Volume No. 37(2)