This multi-compound detection feature proved crucial in identifying adulterants and determining sample authenticity. The chromatographic separation, combined with LCMS confirmation, provided accurate and dependable results for both powder and capsule formulations, making it an ideal tool for forensic analysis and quality control purposes. Further contributing factors included potential adulteration, as additional chromatographic peaks beyond PGL implied other constituents (Figure 5B).
MHRA/CHM Advice: Antiepileptic Drugs: updated advice on switching between different manufacturer’s products (November
- In the MRM mode, precursor and product ions are selected for each target analyte to achieve high selectivity and sensitivity.
- F. MA would like to thank King Khalid University for allowing her to study for a PhD degree as well as the Saudi Food and Drug Authority (SFDA) for providing the opportunity to carry out this work at the Drug Laboratory, SFDA.
- Several samples, which contained numerous substances and manufactured by unauthorized factories for non-medical purposes, were seized in some countries.
- In post-marketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medicinal products, especially with opioids – see Further information.
- The linearity, accuracy, precision, limits of detection (LOD) and quantification (LOQ) were validated according to International Council for Harmonisation (ICH) guidelines (Abraham et al., 2010).
The LOD and LOQ were established based on the calibration curve parameters by using the standard deviation of response (SD) and slope (S) obtained from linear regression of the seven-point calibration curve as per Equations 3, 4, according to ICH Q2 (R1). The precision was determined as the relative standard deviation (RSD%) of replicate measurements at various concentrations, calculated using Equation 2. Intraday precision was pregabalin prices assessed via three replicates for each of three different concentrations (0.75, 1.25, and 2.00 mg/mL) in one run. Inter-day studies analyzed three replicates per concentration of (0.75, 1.25, and 2.00 mg/mL) across six consecutive days. The HPLC assay method for PGL, which was recommended by the British Pharmacopoeia (BP) (British Pharmacopoeia, 2022), was upgraded to a UPLC-PDA method. The linearity, accuracy, precision, limits of detection (LOD) and quantification (LOQ) were validated according to International Council for Harmonisation (ICH) guidelines (Abraham et al., 2010).
Related products
The study combines two analytical methods, i.e., ultra-performance liquid chromatography with photodiode array detector (UPLC-PDA) and LC-MS/MS. The HPLC-UV method recommended by the British Pharmacopoeia (BP) (British Pharmacopoeia, 2022) was upgraded to UPLC-PDA and then validated. Then, the new method was applied for PGL assay in capsule and powder samples while an LC-MS/MS method was performed for confirmation of the adulterated seized samples. In Europe, pregabalin is approved for treatment of neuropathic pain, general anxiety disorder (GAD) and as adjunctive therapy for epilepsy. The purpose of this study was to assess utilisation of pregabalin in the UK, including patients with a recorded history of substance abuse, from a large general practice database.