Analytical Method Development and Validation for Simultaneous Determination of Simvastatin and Mupirocin Using...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Simvastatin (SIM) and mupirocin (MUP) are often used in combination therapies.
• Accurate simultaneous quantification of these drugs is crucial for quality control and therapeutic efficacy.

Purpose of the Study:

• To develop and validate a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of SIM and MUP.
• To assess the drugs' degradation behavior under various stress conditions.

Main Methods:

• Optimization of chromatographic conditions including column, mobile phase composition (acetonitrile/phosphate buffer, pH 3.5), flow rate (1.1 mL/min), and detection wavelength (224 nm).
• Method validation according to International Council for Harmonisation (ICH) guidelines, including specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ).
• Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic stress conditions.

Main Results:

• The developed method achieved good resolution of SIM and MUP with retention times of 2.32±0.008 min and 13.55±0.254 min, respectively.
• High accuracy (99.69±0.82% for MUP, 101.10±0.02% for SIM) and linearity (r² > 0.9959) were observed in the 5-30 µg/mL range.
• Sensitive detection with LOD values of 0.771±0.234 μg/mL for MUP and 0.595±0.282 μg/mL for SIM.

Conclusions:

• The developed RP-HPLC method is specific, sensitive, precise, and accurate for simultaneous SIM and MUP quantification.
• The method is suitable for routine quality control of combined pharmaceutical formulations.
• Forced degradation studies provide insights into the stability profile of both drugs.