Abstract
BackgroundFor the determination of gliclazide and its three potential impurities quantitatively, the development of a stability-indicating, accurate, simple, and fast, Ultra-Performance Liquid Chromatography (UPLC) method was done.ResultsOn Acquity CSH 18 column (50 mm×2.1 mm, 1.7 μ) separation was achieved by the isocratic elution mode using mobile phase (5 mM ammonium acetate buffer of pH 4 and 10% ammonium acetate buffer + 90% acetonitrile, 65/35 v/v). In total, 0.7 mL−1 was the chosen flow rate and UV detection was carried out at 227 nm.ConclusionBy analyzing forced degradation products of the sample, the stability-indicating characteristic of the developed method was proved where the separation of the products of degradation from analyte peak was seen along with spectral purity of gliclazide. Validation of the developed UPLC method was done as per the guidelines of the International Conference on Harmonization in terms of system suitability, precision, accuracy, specificity, sensitivity, linearity, and robustness.
Highlights
For the determination of gliclazide and its three potential impurities quantitatively, the development of a stability-indicating, accurate, simple, and fast, Ultra-Performance Liquid Chromatography (UPLC) method was done
As analytical studies were done using gas chromatography (GC)/MSD or LC-MS are highly expensive and fragile in comparison to ultraperformance liquid chromatography (UPLC) and our main focus was on developing an analytical method that is rapid, accurate, reproducible, and costeffective, UPLC method was chosen for the developing stability-indicating method for determining gliclazide
Specificity Well, separation of degradation products and gliclazide in terms of purity angle and purity threshold was revealed from forced degradation studies
Summary
For the determination of gliclazide and its three potential impurities quantitatively, the development of a stability-indicating, accurate, simple, and fast, Ultra-Performance Liquid Chromatography (UPLC) method was done. For the determination of gliclazide and its potential impurities in pharmaceutical dosage forms, analytical method is required to control and monitor the impurities present in the drug-related substances. On doing a literature survey extensively, it was revealed that for the analysis of gliclazide, several high-performance liquid chromatographies (HPLC) were found but to the best of our knowledge, no reported stability-indicating ultra-performance liquid chromatography method for estimating gliclazide is available. As analytical studies were done using GC/MSD or LC-MS are highly expensive and fragile in comparison to ultraperformance liquid chromatography (UPLC) and our main focus was on developing an analytical method that is rapid, accurate, reproducible, and costeffective, UPLC method was chosen for the developing stability-indicating method for determining gliclazide. The developed method was validated as per the Q2 (R1) guidelines of the International Conference on Harmonization (ICH) and USP compendia procedures [11, 12]
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