Long-term retention and separation reproducibility for analytical scale Fused-core® columns

We present the long-term retention and separation data reproducibility between 2013 and 2020 for analytical scale (4.6 mm internal diameter) superficially porous particle (SPP) columns. The retention factor for a small molecule—naphthalene—separated on 60 randomized manufactured lots, resulted in a 1.04% RSD; for a large molecule—bovine ribonuclease—separated on 31 randomized lots, 1.16% RSD. The peak shapes for three lots within this 7-year period were overlaid to visualize the chromatographic profile reproducibility. Naphthalene’s tailing factor had a % RSD of 4.42 and bovine ribonuclease’s peak width had an % RSD of 2.94; these metrics are sensitive to variability of the total error contribution of the column and system. A small and a large molecule application demonstrated reproducibility using three SPP manufactured lots packed in a narrow bore 2.1 mm i.d. analytical scale format. 15 peaks of the small molecule study resulted with a retention time %RSD reproducibility of ≤ 0.32, and for the large molecule study ≤ 1.12. The information in this study and the detailed discussion of the variability associated to different separation metrics is critical for industries that use HPLC and must adhere to stringent regulatory specifications, e.g., pharmaceutical, food and beverage industry.