Abstract

A stability-indicating reverse phase high performance liquid chromatography method was developed and validated for Migalastat. The wavelength selected for quantitation was 275 nm. The method has been validated for linearity, accuracy, precision, robustness, limit of detection and limit of quantitation. Linearity was observed in the concentration range of 10-50 μg/ml for Migalastat. For RP-HPLC, the separation was achieved by XTerra C 18 (150×4.6 mm) 5 μm column using 0.1% Tri fluro acetic acid: Methanol:Acetonitrile (20:40:40. v/v) as mobile phase with flow rate 0.7 ml/ min. The retention time of Migalastat was found to be 2.6 min respectively. During force degradation, drug product was exposed to hydrolysis (acid and base hydrolysis), H2O2, thermal degradation and photo degradation. In thermal degradation the highest amount of drug was found to be 4.69%. The developed methods were simple, specific and economic, which can be used for simultaneous estimation of Migalastat in capsule dosage form.

Aim and objective: Development of new RP-HPLC method for the estimation of Migalastat in capsule dosage form and then validation of the method.

Method: RP-Hplc Method, stability indicating RP-HPLC method for estimation of migalostat in capsule dosage form validation of the method developed using validation parameters.

Results: The assay of Migalastat was performed with Capsule and the % assay was found to be 100.25 which show that the method is useful for routine analysis.The linearity of Migalastat was found to be linear with a correlation coefficient of 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show precision 0.6 for Migalastat which shows that the method is precise. The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show precision 0.2 for Migalastat which shows that the method is repeatable when performed in different days also. The accuracy limit is the percentage recovery should be in the range of 98.0% - 102.0%. The total recovery was found to be 100.41% for Migalastat. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ are 3 and 10. The LOD and LOQ for Migalastat was found to be 2.98 and 9.97.The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions. The acceptance criteria for degradation studies are less than 15%. The degradation results are within the limit.

Conclusion: The estimation of Migalastat was done by RP-HPLC.

Keywords: Migalostat; RP-HPLC method; Estimation and stability indicating studies; Method development and validation of developed method