Validated high performance liquid chromatography method for determination of miglitol in tablet dosage form

Background

The objective of present investigation was to develop simple, sensitive, specific, precise and accurate reversed-phase high performance liquid chromatographic (RP HPLC) method and subsequent validation of the method for the determination of miglitol in bulk and in tablet dosage form.

Method

The chromatographic method was carried out using Agilent TC-C₁₈ column (250 mm × 4.6 mm i.d., 5 μm particle size) and mobile phase consisting of acetonitrile and 0.02 M phosphate buffer (pH adjusted to 3.5 with orthophosphoric acid) in the ratio of 70:30 v/v. Mobile phase was delivered at the flow rate of 0.8 ml/min. Ultra violet detection was carried out at 220 nm. The elution technique was based on isocratic mode and the sample volume 20 μl was used. The method was validated in terms of linearity, range, specificity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ).

Results

The retention time of miglitol was found to be 4.21 min. The developed method illustrated excellent linearity (r² > 0.99) in the concentration range of 10–50 μg/ml for miglitol. No chromatographic interference from the tablet excipients was found. The mean recoveries were found in the range of 98–102% for miglitol which shows accuracy of the method.

Conclusion

The developed method was found to be accurate, precise, reproducible and specific and can be successfully applied for the quantitative estimation of miglitol in pharmaceutical formulations and routine analysis in quality control laboratories.