Abstract

METHOD DEVELOPMENT AND VALIDATION OF LEMBOREXANT IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE–HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC)

*Muggu. Muralikrishna, S. Nagavalli, Pushpa Anjali, P. Balamani Deep, D. Teja and J. Prem Kumar Naik

Abstract

A simple, precise, rapid, and reproducible RP -HPLC method was developed and validated for the determination of Lemborexant in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a Kromasil-18 ;(ODS) column (250 X 4.6 mm i.d., particle size 3.5μ).The mobile phase consisted of Pentane sulphonic acid sodium salt mono hydrate, add 1ml of Perchloric acid and adjust the pH-2.7±0.05 with Triethyl amine: Methanol in the ratio 40: 60 v/v. An isocratic elution at a flow rate of 1.0 ml/ min at ambient temperature. The detection was carried out at 237 nm using waters UV-Visible detector. The calibration curve was linear in the concentration range of 2–12g/ ml (r2═ 0.9997).The limit of detection and the limit of quantification were found to be 0.273 g/ml and 0.676 g/ml respectively. The amount of Lemborexant present in the formulation was found to be 99.95. The method was validated statistically using the SD, %RSD and SE and the values are found to be within the limits and the recovery studies were performed and the percentage recoveries was found to be 99.55± 0.7211 %. So, the proposed method was found to be simple, specific, linear, and rugged. Hence it can be used for applied for routine analysis of Lemborexant in the Pharmaceutical formulations.

Keywords: Lemborexant, RP-HPLC, UV detection, Development and validation of method; Tablet dosage form.