ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR RELATED SUBSTANCES IN DIPYRIDAMOLE BY RP-HPLCAbstract
Simple RS method is developed and validated as reversed-phase chromatographic method for the identification and quantification of the dipyridamole related substances-A, B, C, D, E and F. Chromatographic separation has been achieved by using Shodex C18, 150 mm, 4.6 mm diameter, 5 µ column, using mobile phase 0.1 % of formic acid and acetonitrile by eluting in gradient with 1.0 ml flow, detection was achieved at 254 nm by maintaining 25 °C temperature for column. The method is validated as per the ICH guidelines. Linearity was recorded at various concentrations ranges 0.0100 – 6.0051 ppm for related substances A, B, C & 0.0040 – 2.4024 ppm of related substances D, E, F. Recovery RSD value of each related substance was <5.0 % (n=9). RS method for related substances in dipyridamole is found specific, linear, accurate, precise, rugged and robust hence the validated method is suitable to identify the related substances in dipyridamole drug.
T. Menaka and B. R. Kuber *
Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), Tirupathi, Andhra Pradesh, India.
07 June 2019
06 November 2019
05 February 2020
01 April 2020