Nevirapine Tablets
DEFINITION
Nevirapine Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of nevirapine (C15H14N4O).
IDENTIFICATION
• A. Infrared Absorption 
197K
197K
Sample:
Transfer a portion of powdered Tablets equivalent to 25 mg of nevirapine to a 50-mL volumetric flask. Dissolve in 10 mL of methylene chloride. Swirl the solution for 30–60 s, and pass through a medium sintered-glass, fritted vacuum funnel. Using a glass syringe, pass the filtrate through a Teflon filter of 0.45-µm pore size. Dry the extract at 105
for a minimum of 1 h.
for a minimum of 1 h.
Acceptance criteria:
Meet the requirements
• B.
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:
Acetonitrile and water (23:77)
Diluent:
Dehydrated alcohol and water (1:1)
System suitability solution:
0.025 mg/mL of USP Nevirapine Anhydrous RS and 0.025 mg/mL of USP Nevirapine Related Compound A RS in Diluent
Standard solution:
0.025 mg/mL of USP Nevirapine Anhydrous RS in Diluent
Sample stock solution:
Nominally 1 mg/mL of nevirapine in Diluent prepared as follows. Transfer nevirapine, from finely powdered Tablets (NLT 20), to a suitable size volumetric flask, and add 75% of the final volume with Diluent. Sonicate the solution for 20 min, then shake for 20 min. Cool to room temperature, and dilute with Diluent to volume. Centrifuge a portion of the resulting solution at 1500 rpm for 5 min.
Sample solution:
Nominally 0.025 mg/mL of nevirapine in Diluent from the Sample stock solution. Filter a portion of the resulting solution, and discard the first 2 mL of the filtrate.
Chromatographic system
Mode:
LC
Detector:
UV 214 nm
Column:
3.9-mm × 15-cm; packing L1
Flow rate:
1 mL/min
Injection size:
20 µL
System suitability
Samples:
System suitability solution and Standard solution
Suitability requirements
Resolution:
NLT 3.0 between nevirapine and nevirapine related compound A, System suitability solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of nevirapine (C15H14N4O) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of nevirapine from the Sample solution |
| rS | = | = peak response of nevirapine from the Standard solution |
| CS | = | = concentration of USP Nevirapine Anhydrous RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration nevirapine in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
Medium:
0.1 M phosphate buffer, pH 2.0 (transferring 3.9 mL/L of concentrated phosphoric acid and 5.73 g/L of monobasic sodium phosphate monohydrate in water, adjust with phosphoric acid to a pH of 2.0 ± 0.02); 900 mL
Apparatus 2:
50 rpm. [Note—Use stainless steel paddles only. Do not use paddles coated with polytetrafluoroethylene. ]
Time:
60 min
Mobile phase, Diluent, Chromatographic system, and System suitability:
Proceed as directed in the Assay.
Standard stock solution A:
0.054 mg/mL of USP Nevirapine Anhydrous RS. Add 10% of the final volume with alcohol and 50% of the final volume of Medium. Sonicate for 20 min to dissolve, allow to cool to room temperature, and dilute with Medium to volume.
Standard stock solution B:
0.028 mg/mL of USP Nevirapine Related Compound A RS. Add 0.8% of the final volume of Diluent, sonicate until completely dissolved, and dilute with Medium to volume.
Standard solution:
0.014 mg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A in Medium
System suitability solution:
0.014 mg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A and 0.014 mg/mL of USP Nevirapine Related Compound A RS from Standard stock solution B in Medium
Sample solution:
Pass 20 mL of the solution under test through a suitable nylon or glass fiber filter of 0.45-µm pore size, and dilute with Medium to obtain a solution having a final concentration of 0.014 mg/mL of nevirapine.
Analysis
Samples:
Standard solution and Sample solution
Determine the percentage of the labeled amount of nevirapine (C15H14N4O) dissolved:
Result = (rU/rS) × (CS/DU) × V × (100/L)
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Nevirapine Anhydrous RS in the Standard solution (mg/mL) |
| DU | = | = dilution factor for the Sample solution |
| V | = | = volume of Medium, 900 mL |
| L | = | = label claim (mg/Tablet) |
Tolerances:
NLT 75% (Q) of the labeled amount of nevirapine (C15H14N4O) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
IMPURITIES
• Organic Impurities
Mobile phase, Diluent, System suitability solution, Sample stock solution, and Sample solution:
Proceed as directed in the Assay.
Standard solution:
0.125 µg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A in Diluent
Chromatographic system:
Proceed as directed in the Assay, except use a run time of at least 13 min.
System suitability
Samples:
System suitability solution and Standard solution
Suitability requirements
Resolution:
NLT 3.0 between nevirapine and nevirapine related compound A, System suitability solution
Relative standard deviation:
NMT 5.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of each impurity in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of each impurity from the Sample solution |
| rS | = | = peak response of nevirapine from the Standard solution |
| CS | = | = concentration of USP Nevirapine Anhydrous RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration nevirapine in the Sample solution (mg/mL) |
[Note—Disregard all peaks due to the solvent or excipients and impurity peaks less than 0.1%. ]
Acceptance criteria
Individual unknown impurity:
NMT 0.1%
Total unknown impurities:
NMT 0.2%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store at controlled room temperature.
• USP Reference Standards 11
11
USP Nevirapine Anhydrous RS 
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USP Nevirapine Related Compound A RS
5,11-Dihydro-6H-11-ethyl-4-methyl-dipyrido[3,2-b:2¢,3¢- e][1,4]diazepin-6-one.
C14H14N4O 254.29
5,11-Dihydro-6H-11-ethyl-4-methyl-dipyrido[3,2-b:2¢,3¢- e][1,4]diazepin-6-one.
C14H14N4O 254.29
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| 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 4040
Pharmacopeial Forum: Volume No. 32(3) Page 807