Validated Stability Indicating UHPLC Method for the Quantification of Escitalopram and Flupentixol in Pharmaceutical Formulation

Raj Patil; Rahul Keshav Godge

doi:10.52756/ijerr.2024.v38.004

Raj Patil Department of Quality Assurance, Pravara Rural College of Pharmacy, Loni BK-413736, Maharashtra, India https://orcid.org/0009-0002-0025-6383
Rahul Keshav Godge Department of Quality Assurance, Pravara Rural College of Pharmacy, Loni BK-413736, Maharashtra, India https://orcid.org/0000-0002-1275-9853

DOI: https://doi.org/10.52756/ijerr.2024.v38.004

Keywords: Escitalopram, forced degradation, flupentixol, UHPLC, validation

Abstract

To assess Escitalopram and flupentixol simultaneously, a verified method for ultra-phase high-performance liquid chromatography (UHPLC) has been developed to indicate stability. The method was thoroughly evaluated and met satisfactory criteria for precision, linearity, accuracy, limits on detection, robustness, and quantitation. The quantitation wavelength of 235 nm was determined. Linearity was successfully demonstrated across concentration ranges of 1–5 µg/ml of Escitalopram and 20-100 µg/ml of Flupentixol. UHPLC separations were conducted employing a Phenomenex L. C18 column measuring 100 x 4.6 mm and containing particles as small as 2.5 µm. To create the mobile phase, the 1% OPA and methanol (a pH of 4.2 with TEA) were combined in a volumetric ratio of 65:35v/v. Escitalopram and Flupentixol were effectively eluted at retention durations of 3.044 and 4.118 minutes, respectively, with the flow rate adjusted at 1.0 ml. The stability-indicating nature of the method was established through validated forced degradation studies. Which included hydrolysis under acidic and basic conditions, exposure to H2O2, thermal degradation, and photo-degradation. Escitalopram and Flupentixol exhibited 10 to 20% degradation under the specified conditions. Importantly, the process evaluated the two prescription drugs in detail with all degradation products generated during the forced degradation experiments. This developed method is characterized as straightforward, specific, and cost-effective, making it suitable for simultaneous estimating Escitalopram and Flupentixol in tabs dose forms.

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