High Performance Liquid Chromatographic Method

701 WordsJan 30, 20163 Pages
A simple, selective and precise stability indicating isocratic reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the determination of buprenorphine hydrochloride in pharmaceutical microemulsion formulation. A forced degradation study of buprenorphine hydrochloride microemulsion formulation was carried out in accordance with International Conference on Harmonization (ICH) guidelines Q1 (R2). The chromatogram was obtained with 10 mmolL−1 potassium phosphate buffer adjusted to pH 6.0 with triethanolamine and acetonitrile (17:83, v/v) as mobile phase, a C-18 column; PrincetonSPHER -100 C18 HPLC column (250 × 4.6 mm i.d., 5 µm) kept at 30◦C and UV detection at 284 nm. The compound was eluted isocratically at a flow rate of 1.0 mL min−1. The average retention time for buprenorphine was 14.319 min. The method was validated according to the ICH guidelines. The validation characteristics included accuracy, precision, linearity, range, specificity, limit of Quantitation and robustness. The calibration curves were linear (R2 > 0.999) over the concentration range 1.0 – 500.0 µgmL−1 for buprenorphine hydrochloride and the recovery study for the compound was above 95 %. No spectral or chromatographic interferences from the microemulsion excipients were found. The drug was found to be labile under oxidative stress condition; whereas, it was stable under all other stress conditions. This method is rapid and simple and does not require any sample
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