Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fluvastatin Sodium in Bulk and Capsule Dosage Form

Abstract

A sensitive, specific and stability-indicating reversed phase high performance liquid chromatography-diode array detection method was developed for the quantitative determination of fluvastatin sodium in the presence of its degradation products. The chromatographic separation was performed on a Phenomenex Luna C18 column (150 X 4.0 mm, 5µm) in isocratic mode using acetonitrile and 0.02M potassium phosphate buffer (50 + 50, v/v, pH 5.0 adjusted with potassium hydroxide) as the mobile phase at a flow rate of 1.0 ml/min. The quantification was performed with a photodiode array detector at 235nm based on peak area. The method showed good linearity over the concentration range of 5-40 µg/mL with a detection limit of 1.1µg/mL and quantification limit of 3.3µg/mL. The proposed LC method was used to investigate the kinetics of acidic and oxidative degradation of fluvastatin sodium. The acidic and oxidative degradation had shown an apparent first-order kinetics and rate constants were found to be 0.0191µg/mL/min and 0.0048µg/mL/min, respectively.

Forced Degradation Study of Statins: A Review

“…Base and oxidative stress resulted in 61.2 % and 43 % drug decomposition, a decrease in original peak area and no additional peaks were observed in the chromatogram. FVS underwent thermal and photolysis degradation slightly (2.65 % and 6.47 %) and no additional peaks were observed in chromatogram [29]. Gomes et al conducted a degradation study on FVS by HPLC method.…”

Untitled

“…Fluvastatin (C 24 H 26 FNO 4 ) is a white crystalline powder that inhibits the enzyme hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase, a rate-limiting step in cholesterol biosynthesis that transforms HMG-CoA to mevalonate [45][46][47][48] .…”

Validated thin‐layer chromatography method for simultaneous determination of sulfacetamide sodium and hydrocortisone acetate in the ophthalmic formulation

“…The key advantages of this system are its visual inspection and flexibility. The limitation of the high-performance TLC approach is that it necessitates a costlier, complex set of instruments and a time-consuming sample preparation step compared to HPLC, UV, and LC-MS/MS [44][45][46][47][48].…”