Development and validation of a fully automated method for the chromatographic determination of content uniformity of drug tablets

Application of 19 F time‐domain NMR to measure content in fluorine‐containing drug products

“…Fluorine is becoming a more common nuclide incorporated in formulated drugs as CF 3 or a single F in the structure of APIs due to its intrinsic physical properties that provide some important biological assets. As fluorinated drugs become more common in the market, an appropriate assay to measure the amount of drug substance in formulated drug products can be developed based on fluorine properties.…”

“…The process can take 1-3 h per sample starting from preparation to analysis, even with automation. [1][2][3] Near-infrared (NIR) has also been used for this assay in a process analytical technology (PAT) setting; however, it requires the use of chemometrics, which makes the process to develop and implement lengthy. [4] In addition, these techniques are destructive, with the formulated drug wasted after the analysis.…”

“…The measurement is done by dissolving the contents of the dosage form in an appropriate solvent or solvent mixture for measurement. The process can take 1–3 h per sample starting from preparation to analysis, even with automation . Near‐infrared (NIR) has also been used for this assay in a process analytical technology (PAT) setting; however, it requires the use of chemometrics, which makes the process to develop and implement lengthy .…”

Leveraging elevated temperature and particle size reduction to extract API from various tablet formulations

“…Samples are extracted using a wet grinding homogenization technique and the system is able to queue up to 100 samples per run. The use of this system has been reported for a number of pharmaceutical dosage forms, including tablets [13][14][15] and capsules [16]. These applications include preparation of individual units and composite samples for assay, content uniformity and purity testing and results obtained using the TPWII were comparable to results obtained using manual sample preparation.…”

Improving method capability of a drug substance HPLC assay

“…between gradient runs [15]. Moreover, it is known from previous studies (Table 1b) [10, [16][17][18][19][20][21][22] that the precision of HPLC is generally poor (>0.5% R.S.D.) compared to that of titration methods, and therefore these methods are supposed to be less capable to meet specification limits [12,23].…”