Cetirizine Hydrochloride Oral Solution
DEFINITION
Cetirizine Hydrochloride Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of C21H25ClN2O3·2HCl.
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.
• B. Identification TestsGeneral, Chloride 191:
Meets the requirements
ASSAY
• Procedure
Solution A:
Acetonitrile
Solution B:
1.36 g/L of monobasic potassium phosphate in water. Adjust with a 2% solution of phosphoric acid in water to a pH of 3.5 ± 0.05.
Diluent:
Acetonitrile and water (3:7)
Mobile phase:
See the gradient table below.
Standard stock solution:
5 mg/mL of USP Cetirizine Hydrochloride RS in water
Standard solution:
0.1 mg/mL of USP Cetirizine Hydrochloride RS in Diluent, from the Standard stock solution
Sample solution:
Transfer an amount of Oral Solution to a suitable volumetric flask to obtain a nominal concentration of 0.1 mg/mL of cetirizine hydrochloride. Dissolve in 60% of the flask volume of Diluent by swirling. Sonicate 3 min, and dilute with Diluent to volume. Pass through a suitable filter.
Chromatographic system
Mode:
LC
Detector:
UV 233 nm
Column:
4.6-mm × 25-cm; 5-µm packing L10
Column temperature:
50
Flow rate:
2 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 1.5
Relative standard deviation:
NMT 1.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C21H25ClN2O3 ·2HCl in the portion of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
90.0%110.0%
PERFORMANCE TESTS
• Deliverable Volume 698:
Meets the requirements
IMPURITIES
Organic Impurities
• Procedure
Solution A:
Transfer 50 mL of water to a 100-mL volumetric flask, add 5.5 mL of sulfuric acid, and dilute with water to volume.
Mobile phase:
Acetonitrile, water, and Solution A (965:33:1)
Diluent:
Acetonitrile and water (7:13)
Standard solution:
6 µg/mL of USP Cetirizine Hydrochloride RS in Diluent
Sample solution:
0.6 mg/mL of cetirizine hydrochloride in Diluent. Transfer an amount of Oral Solution to a suitable volumetric flask, dissolve in Diluent, sonicate for 10 min, and dilute with Diluent to volume. Pass through a suitable filter.
Chromatographic system
Mode:
LC
Detector:
UV 230 nm
Column:
4.6-mm × 25-cm; 5-µm packing L3
Column temperature:
30
Flow rate:
2 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 10,000 theoretical plates
Tailing factor:
NMT 1.5
Relative standard deviation:
NMT 5.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of each impurity in the portion of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
See Impurity Table 1.
Total impurities:
NMT 0.8%
Impurity Table 1
SPECIFIC TESTS
• pH 791:
4.05.1
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62:
The total aerobic microbial count does not exceed 100 cfu/mL, and the total combined molds and yeasts count does not exceed 10 cfu/mL. It meets the requirements of the tests for absence of Escherichia coli.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers, and protect from light. Store at controlled room temperature or in a cold place.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2598
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