Meloxicam Tablets

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

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

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1 DEFINITION

Meloxicam Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of meloxicam (C₁₄H₁₃N₃O₄S₂).

2 IDENTIFICATION

Change to read:

A: The UV absorption spectrum of the meloxicam peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay. 2S (USP41)

B: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Change to read:

Procedure

Solution A: Dissolve 2.0 g of dibasic ammonium phosphate in 1 L of water. Adjust with phosphoric acid to a pH of 7.0 ± 0.1.

Solution B: Methanol and isopropyl alcohol (65:10)

Mobile phase: Solution B and Solution A (37:63)

Standard stock solution 1

For Tablets labeled to contain 7.5 mg/Tablet: 0.75 mg/mL of USP Meloxicam RS, prepared as follows. Transfer a quantity of USP Meloxicam RS to a suitable volumetric flask, dissolve with 2% of the final volume of 1 N sodium hydroxide and 60% of the final volume of methanol, and dilute with methanol to volume.

For Tablets labeled to contain 15 mg/Tablet: 1.5 mg/mL of USP Meloxicam RS, prepared as follows. Transfer a quantity of USP Meloxicam RS to a suitable volumetric flask, dissolve with 2% of the final volume of 1 N sodium hydroxide and 60% of the final volume of methanol, and dilute with methanol to volume.

Standard stock solution 2

For Tablets labeled to contain 7.5 mg/Tablet: 0.075 mg/mL of USP Meloxicam RS, prepared as follows. Transfer a suitable volume of Standard stock solution 1 to an adequate volumetric flask, add 10% of the final volume of 1 N sodium hydroxide, and dilute with methanol to volume.

For Tablets labeled to contain 15 mg/Tablet: 0.15 mg/mL of USP Meloxicam RS, prepared as follows. Transfer a suitable volume of Standard stock solution 1 to a suitable volumetric flask, add 10% of the final volume of 1 N sodium hydroxide, and dilute with methanol to volume. 2S (USP41)

Standard solution

For Tablets labeled to contain 7.5 mg/Tablet: 0.045 mg/mL of USP Meloxicam RS in water from Standard stock solution 2

For Tablets labeled to contain 15 mg/Tablet: 0.09 mg/mL of USP Meloxicam RS in water from Standard stock solution 22S (USP41) Sample stock solution: Transfer 10 Tablets to a 1000-mL volumetric flask, add about 100 mL of 1 N sodium hydroxide, shake to disperse the Tablets, and add 800 mL of methanol. Sonicate the solution for 15 min, then stir for 30 min. Dilute with methanol to volume. Filter the resulting solution, and use the filtrate. The nominal concentration of this solution is 0.075 mg/mL of meloxicam for Tablets labeled to contain 7.5 mg/Tablet and 0.15 mg/mL of meloxicam for Tablets labeled to contain 15 mg/Tablet. 2S (USP41)

Sample solution

For Tablets labeled to contain 7.5 mg/Tablet: Nominally 0.045 mg/mL of meloxicam in water from the Sample stock solution

For Tablets labeled to contain 15 mg/Tablet: Nominally 0.09 mg/mL of meloxicam in water from the Sample stock solution 2S (USP41)

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm. For Identification A, use a diode array detector in the range of 200–400 nm. 2S (USP41)

Columns

Guard: 4-mm × 1-cm; 10-μm 2S (USP41) packing L1

Analytical: 4-mm × 10-cm; 10-μm 2S (USP41) packing L1

Column temperature: 40°

Flow rate: 0.8 mL/min

Injection volume: 25 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of meloxicam (C₁₄H₁₃N₃O₄S₂) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of meloxicam from the Sample solution

r_S = peak response of meloxicam from the Standard solution

C_S = concentration of USP Meloxicam RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

Dissolution 〈711〉

Medium: pH 7.5 phosphate buffer (dissolve 6.81 g of monobasic potassium phosphate in 800 mL of water, adjust with 0.5 N sodium hydroxide to a pH of 7.5, and dilute with water to 1 L); 900 mL

Time: 30 min

Apparatus 2: 75 rpm

Standard stock solution: 0.333 mg/mL of USP Meloxicam RS, prepared as follows. Transfer a quantity of USP Meloxicam RS to a suitable volumetric flask. Add 5% of the total volume of methanol, 1% of the total volume of 0.1 N sodium hydroxide, and dilute with Medium to volume.

Standard solution

For Tablets labeled to contain 7.5 mg/Tablet: 0.008325 mg/mL of USP Meloxicam RS in Medium from the Standard stock solution

For Tablets labeled to contain 15 mg/Tablet: 0.01665 mg/mL of USP Meloxicam RS in Medium from the Standard stock solution 2S (USP41)

Sample solution: Pass portions of the solution under test through a suitable filter of 10-μm pore size. Discard the first few milliliters.

Instrumental conditions

Mode: UV

Analytical wavelength: 362 nm (maximum absorbance)

Cell: 1 cm

Blank: Medium

Analysis

Samples: Standard solution 2S (USP41) and Sample solution

Calculate the percentage of the labeled amount of meloxicam dissolved:

Result = (A_U/A_S) × C_S × V × (1/L) × 100

A_U = absorbance from the Sample solution

A_S = absorbance from the Standard solution 2S (USP41)

C_S = concentration of USP Meloxicam RS in the Standard solution 2S (USP41) (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 70% (Q) of the labeled amount of meloxicam is dissolved.

Uniformity of dosage units 〈905〉: Meet the requirements

5 IMPURITIES

Change to read:

Organic Impurities

Solution A, Solution B, Mobile phase, Standard stock solution 1, Standard stock solution 2, 2S (USP41) Standard solution, Sample stock solution, 2S (USP41) Sample solution, and Chromatographic system: Proceed as directed in the Assay.

Diluent: Methanol, water, and 1 N sodium hydroxide (54:40:6)

Sensitivity solution: 0.000045 mg/mL of USP Meloxicam RS in Diluent from the Standard solution 2S (USP41)

System suitability

Samples: Standard solution and Sensitivity solution 2S (USP41)

Suitability requirements

Tailing factor: NMT 2.0, Standard solution 2S (USP41)

Relative standard deviation: NMT 2.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution 2S (USP41)

Analysis

Samples: Standard solution and Sample solution

2S (USP41)

Calculate the percentage of each impurity in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × (1/F) × 100

r_U = peak response of each impurity from the Sample solution

r_S = peak response of meloxicam from the Standard solution

C_S = concentration of USP Meloxicam RS in the Standard solution (mg/mL)

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

F = relative response factor (see Table 1) 2S (USP41)

Acceptance criteria: See Table 1.

Table 1

6 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Preserve in well-closed containers in a dry place. 2S (USP41) Store at controlled room temperature. 2S (USP41)

USP Reference standards 〈11〉

USP Meloxicam RS