Piroxicam Compounded Oral Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Piroxicam Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of piroxicam (C₁₅H₁₃N₃O₄S).

Prepare Piroxicam Compounded Oral Suspension 10 mg/mL as follows (see Pharmaceutical Compounding - Nonsterile Preparations 〈795〉.

^a Perrigo, Minneapolis, MN.

Pour the weighed Piroxicam powder into a suitable mortar. Wet the powder with a small amount of Ora-Blend, and triturate to make a smooth paste. Add the Ora-Blend in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated container. Add sufficient Ora-Blend to bring the preparation to final volume. Shake to mix well.

2 ASSAY

Procedure

Mobile phase: Mix 500 mL of methanol and 500 mL of 0.1 M sodium acetate, and adjust with phosphoric acid to a pH of 4.0. Add 10 mL of acetonitrile, filter, and degas.

Standard solution: 0.2 mg/mL of piroxicam prepared from USP Piroxicam RS in methanol

Sample solution: Shake thoroughly each bottle of Oral Suspension. Transfer 1.0 mL of the Oral Suspension into a 50-mL volumetric flask, dilute with methanol to volume, and mix well to dissolve. Pass through a PVDF filter of 0.45-μm pore size, discarding the first 3 mL of filtrate.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 361 nm

Column: 3.9-mm × 15-cm; 4-μm packing L7

Flow rate: 1.0 mL/min

Injection volume: 5 μL

System suitability

Sample: Standard solution

[Note - The retention time for piroxicam is about 4.0 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 piroxicam (C₁₅H₁₃N₃O₄S) in the portion of Oral Suspension taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of piroxicam from the Sample solution

r_S = peak response of piroxicam from the Standard solution

C_S = concentration of piroxicam in the Standard solution (mg/mL)

C_U = nominal concentration of piroxicam in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.7–4.7

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at 2°–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 controlled room temperature

USP Reference Standards 〈11〉

USP Piroxicam RS