Original Article

Analytical Method Development and Validation for Simultaneous Determination of Simvastatin and Mupirocin by Reverse Phase Liquid Chromatographic Method

10.4274/tjps.galenos.2020.58897

  • Rupali Kale
  • Pratiksha Shete
  • Dattatray Doifode
  • Sohan Chitlange

Received Date: 13.05.2020 Accepted Date: 16.10.2020 Turk J Pharm Sci 0;0(0):0-0 [e-Pub]

Objectives:

The proposed study is aimed towards development and validation of reverse phase high performance liquid chromatographic method for the simultaneous estimation of Simvastatin and Mupirocin.

Materials and methods:

The chromatographic method developed is optimized for flow rate with column, solvent and buffer used, ratio of mobile phase, molarity and pH. The validation of method optimized and the forced degradation studies of both drugs (for acidic, alkaline, oxidation, heat, light, and neutral conditions) were carried out following the guidelines of the International Harmonization Conference (ICH).

Results:

Kromasil C-18 column (250mm X 4.6mm, 5µm) with UV detection at 224 nm and acetonitrile: phosphate buffer (30 mM) (70:30 v/v) pH 3.5, adjusted with orthophosphoric acid as mobile phase at flow rate of 1.1mL/min were found to give good resolution of Mupirocin and Simvastatin at retention times of 2.32 ± 0.008 min and 13.55 ± 0.254 min, respectively, with high accuracy (% recovery was 99.69 ± 0.82 for Mupirocin, and 101.10 ± 0.02 for Simvastatin) and linearity in the range 5-30 µg/mL (r2=0.9969 for Mupirocin and r2=0.9959 for Simvastatin). The diagnostic limit and the lower limit of determination were 0.771±0.234 and 2.338 ±0.246 μg/mL for Mupirocin, 0.595±0.282 and 1.803±0.334 µg/mL for Simvastatin, respectively. The validated method was used to understand degradation behavior of both the drugs after forced degradation studies.

Conclusion:

Developed method is found to be specific, sensitive, precise and accurate for the simultaneous estimation of Mupirocin and Simvastatin for combined dosage form.

Keywords: Simvastatin, Mupirocin, Validation, Stability indicating