Study on the Quality Control Analysis of Antiepileptic Drugs using High‑performance Liquid Chromatography
Background: Epilepsy is the second most common neurological condition, and antiepileptic drugs (AEDs) are used as a prophylactic measure. Any amount of poor-quality medicine is unacceptable because it increases morbidity and mortality, thus an assessment of quality of AEDs are important in developing countries like India. Phenytoin (PHT) has become a major first‑line AED in the treatment of partial and secondarily generalized seizures, but like other pharmaceuticals, PHT too may develop impurities at various stages of development, transportation, and storage which make the pharmaceutical risky. Hence, the objective of the study was to test PHT concentrations in various injectable medicines available in the local markets of Kashmir Valley. Materials and Methods: Quality analysis of PHT by high‑performance liquid chromatography (HPLC) is more precise and accurate than using other analytical methods such as enzyme‑based assays and immunoassay as the use of HPLC technique in the analytical field helps in structure elucidation and quantitative determination of impurities. In this study, we studied the different parameters of quality of various PHT drugs available in the local markets using HPLC and compared the results obtained with that of the standard. Results: We observed that all the tested PHT sodium injections available in the local market have standard concentrations as all the samples under study showed the peak exactly where the standard PHT peak was supposed to be. Hence, our results suggest that the quality of various PHT drugs used in Kashmir Valley is satisfactory and safe. Conclusion: It is clear from our results that there is a need for a quick and effective drug quality analysis method. As shown from the experiments performed in this study, HPLC is not only a suitable but also efficient system to carry out drug quality evaluation and help curb or at least keep in check the rampant sale of substandard drugs that go unabated in developing countries like India.