Method Development and Validation of Sustained Release Tablets of Propranolol Hydrochloride

Ingle, Aachal V.; Kale, Ravindra H.; Bhagwat, Diptee R.; Sheikh, Aijaz A.

doi:https://doi.org/10.55041/ijcope.v2i5.753

Volume 02, Issue 05

Published on: May 2026

METHOD DEVELOPMENT AND VALIDATION OF SUSTAINED RELEASE TABLETS OF PROPRANOLOL HYDROCHLORIDE

Aachal V. Ingle Ravindra H. Kale Diptee R. Bhagwat Aijaz A. Sheikh

Kailash R. Biyani

Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli, Buldhana, 443201

DOI:https://doi.org/10.55041/ijcope.v2i5.753

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Abstract

The present study reports the development and comprehensive ICH Q2(R1)-compliant validation of a UV spectrophotometric analytical method for Propranolol Hydrochloride (Propranolol HCl), combined with the design and evaluation of sustained release (SR) hydrophilic matrix tablets. Propranolol HCl is a BCS Class I, non-selective β-adrenergic receptor blocker with a short biological half-life (3–6 hours) and extensive first-pass hepatic metabolism, necessitating multiple daily dosing and causing peak-to-trough plasma fluctuations. Seven SR matrix tablet formulations (F1–F7) containing 80 mg Propranolol HCl were prepared by wet granulation using varying ratios of HPMC K4M and HPMC K15M as rate-controlling polymers. The validated UV method (λmax = 220 nm, 0.1N HCl) demonstrated excellent linearity over 2–24 µg/mL (r² = 0.9999), accuracy (% recovery 99.6–100.1%), and precision (%RSD < 1%). All formulations achieved sustained drug release over 12 hours; the Korsmeyer-Peppas model best described release kinetics (r² > 0.9951), with n values of 0.48–0.78 indicating anomalous diffusion-erosion transport. Formulation F4 (HPMC K4M:K15M = 50:50) was identified as optimal, achieving 88.5% cumulative drug release at 12 hours with near-zero-order kinetics. Accelerated stability studies at 40°C/75% RH for 3 months confirmed drug content ≥ 98.9% and consistent dissolution performance. The study demonstrates that integrated analytical validation and HPMC matrix optimization provide a reproducible, clinically relevant SR platform for improved cardiovascular pharmacotherapy.

Keywords: Propranolol Hydrochloride, Sustained Release, HPMC K4M, HPMC K15M, ICH Q2(R1), UV Spectrophotometry, Matrix Tablets, Korsmeyer-Peppas, Wet Granulation.

How to Cite this Paper

Ingle, A. V., Kale, R. H., Bhagwat, D. R. & Sheikh, A. A. (2026). Method Development and Validation of Sustained Release Tablets of Propranolol Hydrochloride. International Journal of Creative and Open Research in Engineering and Management, <i>02</i>(05). https://doi.org/10.55041/ijcope.v2i5.753

Ingle, Aachal, et al.. "Method Development and Validation of Sustained Release Tablets of Propranolol Hydrochloride." International Journal of Creative and Open Research in Engineering and Management, vol. 02, no. 05, 2026, pp. . doi:https://doi.org/10.55041/ijcope.v2i5.753.

Ingle, Aachal,Ravindra Kale,Diptee Bhagwat, and Aijaz Sheikh. "Method Development and Validation of Sustained Release Tablets of Propranolol Hydrochloride." International Journal of Creative and Open Research in Engineering and Management 02, no. 05 (2026). https://doi.org/https://doi.org/10.55041/ijcope.v2i5.753.

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•Published on: May 26 2026

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