HPTLC Method Development and Validation for Rabeprazole Sodium in Pharmaceutical Formulation

Year : 2025 | Volume : 16 | Issue : 02 | Page : 18 24
    By

    Pradeep Kumar,

  • Kamalesh Mistry,

  • Dhananjay Mistry,

  • Shivam Rongpi,

  • Pratyush Kumar Brahma,

  • Mitul Bhoi,

  1. Research Scholar, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  2. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  3. Lecturer, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  4. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  5. Assistant Professor, School of Pharmacy, Rai University, SH-144, village – Saroda, taluka – Dholka, Ahmedabad, Gujarat, India
  6. Assistant Professor, School of Pharmacy, Rai University, SH-144, village – Saroda, taluka – Dholka, Ahmedabad, Gujarat, India

Abstract

Background: The most common medication for acid related disorders stands as Proton pump inhibitor (PPI) Rabeprazole Sodium. The pharmaceutical formulations require essential quality control of Rabeprazole Sodium through reliable analytical methods to maintain reliability. HPTLC provides a cost-effective rapid method for drug quantification compared to conventional HPLC methods so how HPTLC stands as an appropriate method for drug determination. Objective: The emphasis of this research project involves developing and validating a new HPTLC method for quantifying Rabeprazole Sodium in pharmaceutical tablets. Methods: A pre coated silica gel 60 F254 plate operated as the chromatographic separation device under the mobile phase toluene: ethyl acetate: acetic acid (7:3:0.5, v/v/v). It was detected at 245 nm. The method validation process adhered to ICH guideline requirements by assessing linearity along with precision, accuracy, sensitivity, robustness, and ruggedness. Results: The analytical method demonstrated linear behavior between 50–300 ng/spot (r² = 0.9997). The developed method exhibited high sensitivity through its detection limits because LOD had a value of 0.17 µg/mL and LOQ reached 0.62 µg/mL. Recovery studies showed 98.2%–102.1%, ensuring accuracy. Precision studies showed %RSD below 3%. The method demonstrated robustness when the analysis conditions were subjected to minimal changes. Conclusion: The validated HPTLC method offers simple fast accurate economical quality assessment of Rabeprazole Sodium in pharmaceutical products. The validated HPTLC method establishes itself as a preferable method for routine analysis that performs superior to HPLC.

Keywords: Rabeprazole Sodium, HPTLC, Pharmaceutical Tablets, Method Validation, Sensitivity, Linearity, Recovery, Precision, Quality Control.

[This article belongs to Research and Reviews: A Journal of Pharmaceutical Science ]

How to cite this article:
Pradeep Kumar, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. HPTLC Method Development and Validation for Rabeprazole Sodium in Pharmaceutical Formulation. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(02):18-24.
How to cite this URL:
Pradeep Kumar, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. HPTLC Method Development and Validation for Rabeprazole Sodium in Pharmaceutical Formulation. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(02):18-24. Available from: https://journals.stmjournals.com/rrjops/article=2025/view=213578


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Regular Issue Subscription Original Research
Volume 16
Issue 02
Received 03/04/2025
Accepted 11/04/2025
Published 19/06/2025
Publication Time 77 Days
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