Analytical method development and validation for simultaneous estimation of rabeprazole and domperidone by using rp-hplc

Authors

  • Gudepu Shailaja Department Of Pharmaceutical Analysis, Holy Mary Institute Of Technology And Science (College Of Pharmacy), Kondapur Telangana, India
  • Gadipally Sai Kiran Department Of Pharmaceutical Analysis, Holy Mary Institute Of Technology And Science (College Of Pharmacy), Kondapur Telangana, India
  • D. Venkata Ramana Department Of Pharmaceutical Analysis, Holy Mary Institute Of Technology And Science (College Of Pharmacy), Kondapur Telangana, India

DOI:

https://doi.org/10.61096/ijpar.v13.iss4.2024.454-462

Keywords:

Rabeprazole, Domperidone, RP-HPLC, Robustness and ICH Guidelines

Abstract

A rapid, precise, accurate, specific and simple RP-HPLC method was developed for the simultaneous estimation of Rabeprazole and Domperidone in bulk and its combined pharmaceutical dosage form. A High-performance liquid chromatograph WATERS, software: Empower 2, 2695 separation module, 996 PDA detector, using Phenomenex Luna C18 (4.6mm×250mm) 5 µm or equivalent column, with mobile phase composition of Methanol: Phosphate Buffer pH-3.0 (70:30v/v) was used. The flow rate of 1.0 ml min-1 and effluent was detected at 230 nm. The retention time of Rabeprazole and Domperidone was found to be 1.870min and 2.499minutes respectively. Linearity was observed over concentration range of 10-50µg ml-1 for Rabeprazole and 16-80µg ml-1 for Domperidone respectively. The accuracy of the proposed method was determined by recovery studies and the Rabeprazole was found to be 99.1% and Domperidone was found to be 98.8% respectively. The proposed method is applicable to routine analysis of Rabeprazole and Domperidone in bulk and pharmaceutical formulations. The proposed method was validated for various ICH parameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity.

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Published

2024-10-09

How to Cite

Gudepu Shailaja, Gadipally Sai Kiran, & D. Venkata Ramana. (2024). Analytical method development and validation for simultaneous estimation of rabeprazole and domperidone by using rp-hplc. IJPAR JOURNAL, 13(4), 454–462. https://doi.org/10.61096/ijpar.v13.iss4.2024.454-462