Spironolactone Compounded Oral Suspension
DEFINITION
Spironolactone Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of spironolactone (C24H32O4S). Prepare Spironolactone Compounded Oral Suspension 5 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).Crush the Spironolactone tablet(s) to a fine powder, and pass through a 40-mesh sieve. Wet the powder with a small amount of Ora-Blend, and triturate to make a smooth paste. Add the Ora-Blend to make the mortar contents pourable. Transfer the contents stepwise and quantitatively to a calibrated container using the remainder of the Ora-Blend. Add sufficient Ora-Blend to bring to final volume. Shake to mix well.
ASSAY
• Procedure
Mobile phase:
Mix 435 mL of water with 2.7 mL of phosphoric acid and 50 mL of methanol. Combine the solution with 515 mL of acetonitrile and mix well. Filter and degas.
Standard solution:
0.2 mg/mL of USP Spironolactone RS in Mobile phase
Sample solution:
Shake each bottle of Oral Suspension thoroughly. Transfer 1.0 mL of Oral Suspension into a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix well to dissolve.
Chromatographic system
Mode:
LC
Detector:
UV 238 nm
Column:
4.6-mm × 25-cm; 5-µm packing L11
Flow rate:
1.0 mL/min
Injection volume:
10 µL
System suitability
Sample:
Standard solution
[Note—The retention time for spironolactone is about 10.7 min. ]
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0% for replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of spironolactone (C24H32O4S) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of spironolactone from the Sample solution |
| rS | = | = peak response of spironolactone from the Standard solution |
| CS | = | = concentration of spironolactone in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of spironolactone in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
3.6–4.6
791:
3.6–4.6
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at 2
–8 or at controlled room temperature.
–8 or at controlled room temperature.
• Labeling:
Label it to indicate that it is to be well shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date:
NMT 90 days after the date on which it was compounded when stored at 2–8 or at controlled room temperature
–8 or at controlled room temperature
• USP Reference Standards 11
11
USP Spironolactone RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun, Pharm.D.
Associate Scientific Liaison (301) 230-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 5348
Pharmacopeial Forum: Volume No. 39(5)