Development of Robust RP-HPLC Method for Concurrent Analysis of Aliskiren and Amlodipine in Combined Tablet Dosage Form

Lakshmana Rao  Atmakuri; Saidatri  Arige; Bhavani Devi  Sriram; Vijaya Kumar  Ghanta; Ramesh  Alluri; Suresh Babu  Madda

doi:10.5530/ctbp.2025.2s.9

Authors

Lakshmana Rao Atmakuri V. V. Institute of Pharmaceutical Sciences, Gudlavalleru – 521 356, Andhra Pradesh, India
Saidatri Arige V. V. Institute of Pharmaceutical Sciences, Gudlavalleru -521 356, Andhra Pradesh, India
Bhavani Devi Sriram V. V. Institute of Pharmaceutical Sciences, Gudlavalleru -521 356, Andhra Pradesh, India
Vijaya Kumar Ghanta KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada – 520 010, Andhra Pradesh, India
Ramesh Alluri Vishnu Institute of Pharmaceutical Education & Research, Narsapur – 502 313, Telangana, India
Suresh Babu Madda School of Pharmacy, GIET University, Gunupur – 765 022, Odisha, India

DOI:

https://doi.org/10.5530/ctbp.2025.2s.9

Keywords:

Aliskiren, Amlodipine, Hypertension, RP-HPLC, Validation, Quality Control

Abstract

Present research focuses on development & validation of a robust RPHPLC method for the concurrent estimation of Aliskiren & Amlodipine in collective tablet dosage forms. The mixture of Aliskiren, selective renin inhibitor, & Amlodipine, calcium channel blocker, is commonly prescribed for the management of hypertension. The primary purpose of research was to establish a fast, accurate, & stability-indicating RP-HPLC method that can reliably quantify both active pharmaceutical ingredients (APIs) in a single analytical run. The method was validated as per ICH guidelines, confirming its precision, linearity, accuracy, & sensitivity. Optimized chromatographic conditions included an acetonitrile and hexane sulfonic acid mixture (55:45 v/v) as mobile phase, which provided adequate resolution & quick retention times for both compounds. Method demonstrated excellent linearity with Aliskiren concentration ranging from 15 to 225 μg/mL & Amlodipine from 1 to 15 μg/mL. Retention times for Aliskiren & Amlodipine were 2.716 minutes & 7.351 minutes, respectively. Method proved suitable for routine analysis & stability testing, offering high sensitivity & reliable results for the quantification of Aliskiren & Amlodipine in tablet formulations under stressed conditions.