Assessment and Computational Estimation of Omeprazole and Levosulpiride Impurities in Fixed Dose Combination by AQbD Approach

Abstract

This study focuses on novel high-performance liquid chromatography (HPLC) method to simultaneously identify and quantify degradation products of esomeprazole and levosulpiride in capsule dosage form, enhancing analytical precision and reliability. The gradient was thoroughly optimized for proper separation of all the peaks in the chromatogram. Chromatographic separation was obtained on Octadecylsilane 250 x 4.6 mm, 5 µm column. Mobile phase A consisting of buffer (Ammonium acetate 50 mM) pH 5.0: Acetonitrile: Water, in ratio 10:10:80 (v/v), whereas mobile phase B consisting of Acetonitrile and Water in ratio 80:20 (v/v). Gradient programme was set as follow: time in min/% of mobile phase A 0/100, 10/80, 15/80, 30/20, 35/100, 45/100. The flow rate was 1.0 mL/min^-1 with UV detection at 302 nm. The method development incorporated an analytical quality by design (AQbD) approach, offering a systematic optimization strategy employing Box-Behnken design. The developed method was aligned and validated according to the ICH guidelines.

Received: 23 July 2024 | Revised: 21 October 2024 | Accepted: 15 November 2024

Conflicts of Interest

The authors declare that they have no conflicts of interest to this work.

Data Availability Statement

Data available on request from the corresponding author upon reasonable request.

Author Contribution Statement

Vikram Gharge: Conceptualization, Supervision, Project administration; Satish Jadhao: Conceptualization, Methodology, Supervision, Project administration; Balasaheb Jadhav: Methodology; Pranav Bang: Software, Formal analysis, Investigation, Data curation, Writing - original draft, Writing - review & editing, Visualization; Gurudatt Hendge: Validation, Formal analysis, Data curation, Writing - original draft, Writing - review & editing, Visualization; Nayan Jadhav: Formal analysis, Investigation, Data curation, Writing - original draft, Writing - review & editing, Visualization; Rutuja Mulik: Formal analysis, Resources, Data curation, Writing - original draft, Writing - review & editing, Visualization; Shubham Bhange: Formal analysis, Investigation, Data curation, Writing - original draft, Writing - review & editing, Visualization; Laxman Ingole: Formal analysis, Resources, Data curation, Writing - original draft, Writing - review & editing, Visualization.