Abacavir Oral Solution
Abacavir Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of abacavir (C14H18N6O).
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Solution A: Trifluoroacetic acid and water (0.05:99.95)
Solution B: Methanol and water (17:3)
Diluent: 1 mL of phosphoric acid diluted with water to 1000 mL
Mobile phase: See the gradient table below.
System suitability solution: 0.2 mg/mL of USP Abacavir System Suitability Mixture RS in Diluent
Standard solution: 0.46 mg/mL of USP Abacavir Sulfate RS in Diluent
Sample solution: Equivalent to 0.4 mg/mL of abacavir in Diluent, from Oral Solution. [NoteSonicate, if necessary. ]
Detector: UV 254 nm
Column: 3.9-mm × 15-cm; 5-µm packing L1
Column temperature: 30
Flow rate: 0.8 mL/min
Injection size: 10 µL
Samples: System suitability solution and Standard solution
Resolution: NLT 1.5 between abacavir and trans-abacavir, System suitability solution
Relative standard deviation: NMT 2.0%, Standard solution
Samples: Standard solution and Sample solution
Calculate the percentage of C14H18N6O in the portion of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
Acceptance criteria: 90.0%110.0%
• Deliverable Volume 698: Meets the requirements
Solution A, Solution B, Diluent, Mobile phase, System suitability solution, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.
Sensitivity solution: 0.2 µg/mL of USP Abacavir Sulfate RS in Diluent, from the Standard solution. [NoteThe concentration of this solution is 0.05% of the nominal concentration of the Sample solution. ]
Samples: Diluent, Standard solution, Sample solution, and Sensitivity solution. [NoteIn the Sample solution disregard any peaks corresponding to peaks identified in the Diluent and any peak with a peak area less than the abacavir peak area in the Sensitivity solution. ]
Calculate the percentage of each impurity in the portion of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × (1/F) × (Mr1/Mr2) × 100
Individual impurities: See Impurity Table 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 yeast count does not exceed 10 cfu/mL. It also meets the requirement for absence of Escherichia coli.
• pH 791: 3.84.5
• Packaging and Storage: Preserve in well-closed containers. Store at controlled room temperature.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2022Pharmacopeial Forum: Volume No. 36(3) Page 652