Development and validation of novel HPLC method for analytical evaluation of Lemborexant in tablet dosage form

A simple and novel isocratic high-performance liquid chromatography (HPLC) method was developed for quantitative determination of lemborexant in bulk as well as in its tablet dosage form. The developed HPLC method was validated as per ICH (Q2R1) guideline. The results of validation parameters indicate that developed HPLC method was specific, accurate, precise, rapid, reliable and reproducible. Therefore, it can be applied for routine quality control analysis of Lemborexant in bulk and tablet dosage form. Materials and Methods: The chromatographic separation was achieved on Thermoscientific BDS Hypersil (C18, 15 cm × 4.6 mm id, 5μ) column. The mobile phase consisting of buffer (triethylamine (0.1% v/v) adjusted to pH 3.0 with orthophosphoric acid) and acetonitrile in the ratio of (60:40) was passed through the column maintained at 40 °C with a flow rate of 1 ml/min. Approximately 20 µl of the solution was injected and the analyte was eluted at 265 nm.

Results: The retention time of lemborexant was around 7.77 min. The percentage RSD of each parameter was found within the limit. The recovery of lemborexant was found to be 100.71%. LOD and LOQ values of lemborexant were found to be 0.54 µg/ml and 1.6 µg/ml respectively. The method was linear over the range of 10-70 µg/ml with a regression coefficient 0.9996. All the verification parameters were within the range according to ICH guidelines.

Conclusion: The developed RP-HPLC method is economical, simple, and practical and useful in routine analysis of Lemborexant in bulk and tablet dosage form.