“Regular reviews and monitoring for signs of misuse, diversion, and dependence are imperative for all patients,” she says. Control chart based on assay distribution between British Pharmacopoeia (BP) specifications (95%–105%) for the analysis of 35 capsule samples, as determined by the UPLC-PDA method, showing that 31.43% of these samples failed to meet the BP limit. The central nervous system-depressant effects of gabapentinoids are additive when used with other centrally-acting drugs, particularly opioids, and caution is advised when they are prescribed together. Along with gabapentin, lyrica cost canada pregabalin is a gabapentinoid — an analogue of the neurotransmitter γ-aminobutyric acid (GABA) that exerts its effect by inhibiting calcium-mediated neurotransmitter release — and a popular alternative to prescribing opioids.
- The proposed oxidative degradation pathway involves sequential formation of mono-hydroperoxide, cyclized hydroperoxide, dihydroperoxide and hydroxy derivatives that eventually degrade into multiple products (Vukkum et al., 2015).
- The central nervous system-depressant effects of gabapentinoids are additive when used with other centrally-acting drugs, particularly opioids, and caution is advised when they are prescribed together.
- LC-MS/MS analysis was performed to investigate the seized capsules and powder samples to identify any potential adulterants.
- Only 1.0% (136/13,480) of patients were prescribed an ADD of pregabalin over the maximum approved dose of 600 mg/day.
- Another study reported that variations in the manufacturing process could result in significant differences in the uniformity of PGL formulations, which may have a reverse effect on patient safety (Gujral et al., 2009).
Reference
Patient demographics, diagnoses (by READ codes) and pregabalin dosing data were collected. The authors at the Saudi Food and Drug Authority (SFDA) are grateful to the General Directorate of Narcotics Control (GDNC) in Saudi Arabia for supporting this research and providing seized samples of PGL. 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. This approach not only improved separation efficiency but also met forensic requirements for rapid analysis and aligned with green chemistry principles by reducing solvent consumption while maintaining compliance with pharmacopeial standards.
1 UPLC-PDA Method validation
These analytical challenges necessitate the development of more efficient assay methods, particularly for confirmation analysis of PGL when it is suspected to contribute to adverse clinical presentations or toxicities (Mutalabisin et al., 2021). In this context, a limited number of analytical methods were developed for PGL quantification in various sample matrices for clinical and forensic applications. LC with mass spectrometric detections (MS), including tandem MS and TOF-MS methods, are dominant in the literature. Environmental analysis of urban sewage samples for determination of PGL was also reported using LC-MS/MS (Gurke et al., 2015).
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