Lovastatin 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

Lovastatin Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of lovastatin (C₂₄H₃₆O₅).

2 IDENTIFICATION

A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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

Procedure

Buffer: Dissolve 3.45 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.0, and dilute with water to 1000 mL.

Mobile phase: Acetonitrile, methanol, and Buffer (50:10:30)

Solution A: Mix 3.0 mL of glacial acetic acid with 900 mL of water in a 1-L beaker, and adjust with 20% sodium hydroxide solution to a pH of 4.0. Transfer the contents of the beaker to a 1000-mL volumetric flask, and dilute with water to volume.

Diluent: Acetonitrile and Solution A (80:20)

Standard solution: 40 μg/mL of USP Lovastatin RS in Diluent

Sample stock solution: Nominally 0.2 mg/mL of lovastatin prepared as follows. Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 40 mg of lovastatin, to a 200-mL volumetric flask. Add 150 mL of Diluent, and sonicate for 20 min. Cool to room temperature, and allow the solution to stand for 30 min. Dilute with Diluent to volume. Centrifuge a portion of this solution, and use the supernatant.

Sample solution: Nominally 40 μg/mL of lovastatin in Diluent from Sample stock solution

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm. For Identification A, use a diode array detector in the range of 200–400 nm.

Column: 4.6-mm × 25-cm; 5-μm packing L1

Column temperature: 45°

Flow rate: 1.5 mL/min

Injection volume: 50 μL

Run time: NLT 2.5 times the retention time of lovastatin

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 lovastatin (C₂₄H₃₆O₅) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U= peak response of lovastatin from the Sample solution

r_S = peak response of lovastatin from the Standard solution

C_S = concentration of USP Lovastatin RS in the Standard solution (μg/mL)

C_U = nominal concentration of lovastatin in the Sample solution (μg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: 1.38 g of monobasic sodium phosphate and 20 g of sodium lauryl sulfate in 900 mL of water. Adjust with 1 N sodium hydroxide to a pH of 7.0, and dilute with water to 1000 mL; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Mobile phase: Proceed as directed in the Assay.

Standard solution: Weigh 44 mg of USP Lovastatin RS into a 500-mL volumetric flask, and dissolve in NMT 20 mL of methanol. Dilute with

Medium to volume. Further dilute this solution with Medium to obtain a final concentration of L/900 mg/mL, where L is the label claim in mg/Tablet.

Sample solution: Pass the solution under test through a suitable filter of 0.45-μm pore size.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 4.6-mm × 5-cm; 5-μm packing L1

Flow rate: 2 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

Suitability requirements

Capacity factor, k′: NLT 2.0

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 lovastatin (C₂₄H₃₆O₅) dissolved:

Result = (r_U/r_S) × (C_S × V) × (100/L)

r_U = peak response of lovastatin from the Sample solution

r_S = peak response of lovastatin from the Standard solution

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

V = volume of Medium, 900 mL

L = label claim of lovastatin (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of lovastatin (C₂₄H₃₆O₅) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Change to read:

Organic Impurities

Buffer, Mobile phase, Solution A, Diluent, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

System suitability solution: 4 μg/mL of USP Mevastatin RS and 4 μg/mL of USP Lovastatin RS in Diluent

Sensitivity solution: 0.08 μg/mL of USP Lovastatin RS in Diluent from the Standard solution

System suitability

Samples: Standard solution, System suitability solution, and Sensitivity solution

Suitability requirements

Resolution: NLT 2.0, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of lovastatin acid and any unspeci

ed degradation product in the portion of Tablets taken:

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

r_U = peak response of lovastatin acid or any unspecified degradation product from the Sample solution

r_S = peak response of lovastatin from the Standard solution

C_S = concentration of USP Lovastatin RS in the Standard solution (μg/mL)

C_U = nominal concentration of lovastatin in the Sample solution (μg/mL)

F = relative response factor (see Table 1)

Acceptance criteria: See Table 1.

Table 1

a Preservative in the formulation; if present, not included in the calculation.

b (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-Dimethyl-8-{[(S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid.

c For resolution measurement only.

d Total degradation products is the sum of all related compounds except lovastatin acid.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed, light-resistant containers. Protect from light, and store either in a cool place or at controlled room temperature.

USP Reference Standards 〈11〉

USP Lovastatin RS

USP Mevastatin RS

(1S,7S,8S,8aR)-8-{2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (S)-2-methylbutanoate.