LIQUID CHROMATOGRAPHIC METHOD FOR THE SEPARATION OF ANOMERS OF MIGLITOL

Abstract

A simple, inexpensive, and rapid liquid chromatography (LC) method has been developed for the quantitative determination of anomers of Miglitol, an oral anti diabetic drug. Degradation studies were performed on the bulk drug by heating to 60°C, exposure to UV light at an energy of 200 Watt hours/m²and to Visible light at an illumination of not less than 1.2 million lux hours, acid (0.1 N hydrochloric acid), base (0.1 N sodium hydroxide) aqueous hydrolysis, and oxidation with 6.0% v/v hydrogen peroxide. Good resolution between the peaks corresponding to anomeric impurities, degradation products, and the analyte was achieved on a Waters amino column using a mobile phase consisting of a mixture of aqueous ammonium dihydrogen phosphate and acetonitrile. The degradation samples were assayed against the reference standard of Miglitol and the mass balance in each case was close to 99.0%. Validation of the method was carried out as per International Conference on Harmonization (ICH) requirements.

Keywords:

• amino column
• anomers
• column liquid chromatography
• degradation studies
• method validation
• Miglitol

ACKNOWLEDGMENT

The authors wish to thank the management of Dr. Reddy's group for supporting this work. The authors wish to acknowledge the Process Research Group for providing the samples.

Notes

Linearity range is LOQ 150% with respect to 10.0 mg/mL Miglitol for impurities.

# six determinations using 0.2% spiked solution of impurities to analyte.