Stability-indicating RP-HPLC method for estimation of miglitol in bulk and tablets
1School of Pharmaceutical Sciences, Jaipur National University, Jagatpura, Jaipur-302 025, India 2Torent Pharmaceutical Pvt. Ltd., Ahmadabad, 380 009, India
U S Baghel School of Pharmaceutical Sciences, Jaipur National University, Jagatpura, Jaipur-302 025 India E-mail: [email protected]
A selective and sensitive, stability-indicating reverse phase high performance liquid chromatography method has been first developed and validated for the estimation of miglitol in bulk and tablet dosages form. Samples were separated on a prepacked, Inertsil amino C 18 column (150Χ4.6 mm i.d.) using a mobile phase comprised of acetonitrile and monobasic sodium phosphate pH 7.5 (80:20, v/v) delivered at 1.5 ml/min flow rate. Detection was performed on a SPD-20A prominence UV/Vis detector at 220 nm. The retention time for miglitol was 13.93±0.0367. The method was validated in terms of linearity, precision, accuracy, ruggedness, and specificity, limit of detection and limit of quantification. The linearity (r 2 ) and percentage recoveries of miglitol were 0.9986 and 99.85%. This method is suitable for routine estimation of miglitol in bulk and tablet dosages form.