Stability Indicating Rp-HPLC Method for Estimation of Repaglinide in Rabbit Plasma

Abstract

Objective: A simple, selective and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method to estimate repaglinide (REP) in rabbit plasma using rabeprazole (RAB) as an internal standard was developed and validated for various qualifications.
 Methods: The chromatographic separation was performed on C18 (2) analytical column (5 μ, 250×4.6 mm) using acetonitrile: 0.05% trifluoroacetic acid in water (55:45, v/v) as mobile phase at the flow rate of 1 ml/min. Validation of the analytical method was performed as per ICH guidelines.
 Results: The retention times of REP and RAB were found at ~4.3 and 5.1 min respectively, with adequate system suitability parameters (theoretical plates ≥3619, tailing factor ≤1.38, resolution factor 2.37). The method has linearity over a concentration range of 10 to 1000 ng/ml (r2=0.9987). The results of accuracy (≥98.17%), intra-, inter-day precision (≤2.9%), recovery (101.21±2.09%) and process efficiency (99.77±3.74%) found satisfactory with no matrix effect. The analyte in samples were found stable up to 6 h, 3 freeze-thaw cycles and not more than 2 mo corresponding to bench-top, short and long term stability studies respectively.
 Conclusion: The developed RP-HPLC method for estimation of REP in rabbit plasma was developed. The method was found to be rapid, cost-effective and accurate to estimate the REP from the sample matrix. The method can be a most useful tool for in vivo study of REP in the rabbit.

A stability indicating method development and validation of a rapid and sensitive RP-HPLC method for Nintedanib and its application in quantification of nanostructured lipid carriers

“…The peak area, retention time and %RSD were determined. 20 Forced or stress degradation studies Force degradation studies were performed to determine the stability of NTB in the developed analytical method by exposing it to various stress as discussed below. 21 Acid degradation 0.1 N HCl was added into 4 μg/ml of standard NTB solution, and the solution was subjected to heating by using the reflux condensing method for 60 min at 85°C temperature.…”

Pharmacokinetic Investigation to Study the In Vivo Bioavailability of Thiolated Chitosan Based Repaglinide Buccal Tablets

“…The particle free clear supernatant (20 µL) was allowed to inject into the HPLC column [C18 (2), 250×4.6 mm; 5µ particle size (Luna®, Phenomenex)] to develop the chromatogram by isocratic elution using a fixed composition of ACN:0.05% trifluoroacetic acid (TFA) in water (55:45, %v/v) mixture as mobile phase, pumped with constant flow rate (1 mL/ min) and 285 nm was set as detection wavelength for entire study. 33…”