*Corresponding Author: rahulgodge@gmail.com 37 DOI: https://doi.org/10.52756/ijerr.2024.v38.004 Int. J. Exp. Res. Rev., Vol. 38: 37-45(2024) Validated Stability Indicating UHPLC Method for the Quantification of Escitalopram and Flupentixol in Pharmaceutical Formulation Raj Patil and Rahul Godge* Department of Quality Assurance, Pravara Rural College of Pharmacy, Loni BK-413736, Maharashtra, India E-mail/Orcid Id: RP, rajapatil32000@gmail.com, https://orcid.org/0009-0002-0025-6383; RG, rahulgodge@gmail.com, https://orcid.org/0000-0002-1275-9853 Introduction Escitalopram oxalate (ESC) is utilized in the treatment of depression and anxiety, functioning by restoring the balance of serotonin, a natural substance in the brain. Flupentixol HCI (FLU) is employed to alleviate symptoms associated with Schizophrenia and other mental health disorders. Numerous analytical methods for evaluating pharmaceutical drugs in various formulations. A comprehensive literature review has disclosed a range of analytical methods for estimating ESC alone and in combination with other drugs. Similarly, different methods are available for determining FLU alone and in combination with other drugs. Although there is a UV- spectroscopic method for Simultaneous determination of ESC (escitalopram) and FLU (flupentixol) in a combined dosage form (Goulikar et al., 2022; Patel et al., 2016; Darthi et al., 2018; Singh et al., 2016; Sakhreliya et al., 2012) also it was achieved using RP-HPLC for Analysis of ESC and FLU in combined dosage form and with other drugs reported in the literature (Panchale et al., 2021; Sellappan et al., 2021; Damor et al., 2017; Kakde et al., 2013; Kadam et al., 2022; Stefan et al., 2022; Beula et al., 2022; Nagar et al., 2015; Bindusar et al., 2019; Kumar et al., 2022; Nagar et al., 2015). HPTLC method is also available for determining FLU and ESC in combined dosage form (Malathi et al., 2022). Validated analytical method development for other combination by Rp-HPLC (Gosavi et al., 2023) with stability by Rp-HPLC method for other drugs which is referred for stability parameters (Dey et al., 2020; Deshpande et al., 2023). None have encompassed complete validation according to ICH Article History: Received: 22 nd Dec., 2023 Accepted: 08 th March, 2024 Published: 30 th Apr., 2024 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. Keywords: Escitalopram, forced degradation, flupentixol, UHPLC, validation How to cite this Article: Raj Patil and Rahul Godge (2024). Validated Stability Indicating UHPLC Method for the Quantification of Escitalopram and Flupentixol in Pharmaceutical Formulation. International Journal of Experimental Research and Review, 38, 37-45. DOI: https://doi.org/10.52756/ijerr.2024.v38.004