Development and validation of two stability-indicating UV-spectrophotometric methods for the determination of repaglinide in bulk and dosage forms.

摘要

Two stability indicating UV-spectrophotometric methods were developed and validated for the detn. of repaglinide with its degrdn. products. Assay of repaglinide in 0.1M NaOH and 0.1M HCl were achieved at 216nm and 243nm resp. The correlation was in the range of 1.0-25 μg mL-1 (r = 0.9999) for 0.1M NaOH and 2.0-40 μg mL-1 (r = 0.9999) for 0.1M HCl with molar absorptivity values of 2.02 × 104 L mol-1 cm-1 and Sandell sensitivity of 0.0224 μg cm-2 for 0.1M NaOHand 1.17 × 104 L mol-1 cm-1 and Sandell sensitivity of 0.0386 μg cm-2 for 0.1M HCl. The detection limit and quantification limit are calcd. to be (0.13, 0.39 μg mL-1) and (0.18 and 0.54 μg mL-1) for 0.1M NaOH and 0.1M HCl resp. The method was validated for accuracy, precision, robustness, selectivity and applied for marketed formulations with less than 2% relative error and std. deviation. [on SciFinder(R)]