Haloperidol Tablets
DEFINITION
Haloperidol Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of haloperidol (C21H23ClFNO2).
IDENTIFICATION
• A.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Mobile phase:
Methanol and 0.05 M monobasic potassium phosphate buffer (60:40). Adjust with 1 N sodium hydroxide or phosphoric acid to a pH of 4.0.
Standard solution:
0.1 mg/mL of USP Haloperidol RS in Mobile phase
Sample solution:
Nominally 0.1 mg/mL of Haloperidol prepared as follows. Transfer an equivalent of about 10 mg of haloperidol from NLT 20 finely powdered Tablets to a 100-mL volumetric flask. Add 60 mL of Mobile phase, sonicate for 10 min, and shake by mechanical means for about 1 h. Dilute with Mobile phase to volume, mix, and filter, discarding the first 20 mL of the filtrate.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
3.9-mm × 25-cm; packing L1
Flow rate:
1 mL/min
Injection size:
15 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of haloperidol (C21H23ClFNO2) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of the Sample solution |
| rS | = | = peak response of the Standard solution |
| CS | = | = concentration of USP Haloperidol RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of haloperidol in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 
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711
Medium:
Simulated gastric fluid TS without enzyme; 900 mL
Apparatus 1:
100 rpm
Time:
60 min
Mobile phase:
Prepare as directed in the Assay.
Standard solution:
A known concentration of USP Haloperidol RS in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary, to a concentration that is similar to that of the Standard solution.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
3.9-mm × 25-cm; packing L1
Flow rate:
1 mL/min
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 3.0%
Tolerances:
NLT 80% (Q) of the labeled amount of haloperidol (C21H23ClFNO2) is dissolved.
• Uniformity of Dosage Units 905
905
Procedure for content uniformity
Standard solution:
20 µg/mL of USP Haloperidol RS in warm methanol
Sample solution:
20 µg/mL of haloperidol from 1 finely powdered Tablet in warm methanol. Shake for 15 min and filter, discarding the first 20 mL of the filtrate.
Instrumental conditions
Mode:
UV
Analytical wavelength:
245 nm
Cell:
1 cm
Blank:
Methanol
Analysis:
Concomitantly determine the absorbances of the Standard solution and Sample solution at the wavelength of maximum absorbance.
Calculate the percentage of the labeled amount of haloperidol (C21H23ClFNO2) in the portion of Tablets taken:
Result = (AU/AS) × (CS/CU) × 100
| AU | = | = absorbance of the Sample solution |
| AS | = | = absorbance of the Standard solution |
| CS | = | = concentration of USP Haloperidol RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of haloperidol in the Sample solution (µg/mL) |
Acceptance criteria:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• USP Reference Standards 11
11
USP Haloperidol RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ravi Ravichandran, Ph.D.
Principal Scientific Liaison 1-301-816-8330 |
(SM42010) Monographs - Small Molecules 4 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3399