Automated Sample Prep for CU and Assay of Rosuvastatin Tablets

Manual sample preparation methods for Content Uniformity and Assay of Rosuvastatin Calcium Tablets were automated on the accroma® samplePrep system.

The goal was to reduce extraction and overall sample preparation hands-on times, while improving data quality and reducing human errors.

The reference standard, 10 individual tablets for Content Uniformity, and 5 tablets for Assay were automatically prepared. The extraction was done by vertical shaking of accroTubes with 16mm steel balls as grinding and mixing aids. The measured contents of all samples were all within 102% and 105%, which are within specification. The relative standard deviation (RSD) of the ten Content Uniformity measurements was calculated to 0.98%.

The estimated overall hands-on time could be reduced by 83% for Content Uniformity and by 87.5% for Assay without counting documentation efforts.