Fast Stability-Indicating HPLC Method for the Simultaneous Evaluation of Amlodipine Besylate, Indapamide, Perindopril Erbumine, and Their Degradation Products in Pharmaceutical Formulations

Year 2025, Volume: 55 Issue: 2, 274 - 281, 23.09.2025

Filiz Demir , Sıdıka Toker , Serdar Ünlü

https://doi.org/10.26650/IstanbulJPharm.2025.1465651

Abstract

Background and Aims: This study aims to develop a stability-indicating and fast analytical method using reversed-phase high-pressure liquid chromatography (RP-HPLC) to determine amlodipine besylate (AMB), indapamide (IND), and perindopril erbumine (PRE) in pharmaceutical dosage forms.

Methods: In the developed chromatographic method, the active substances of pharmaceutical dosage forms were separated on an InertSustain C8 (150 mm × 4.6 mm, 3 µm) column using a mobile phase at pH 2 containing heptane acid sodium salt and acetonitrile as ion pair buffer and monitored at a detection wavelength of 215 nm. The column temperature of the method was 30 °C. The injection volume was 20 μL. The flow rate was 1.0 mL/min. The developed method was validated and then forced degradation studies were carried out according to the ICH guideline “Q2(R2) Stability testing of new drug substances and products”.

Results: Under the chromatographic conditions described above, the retention times of PRE, IND, and AMB were recorded as 7.7 ± 0.5 min, 10.2 ± 0.5 min and 15.5 ± 0.5 min, respectively. The linearity ranges were found out to be 0.2774–0.8322, 0.025–0.075, mg/ml and 0.0814–0.2442 mg/ml for AMB, IND, and PRE, respectively. Correlation coefficients were found to be more than 0.9990 for all. Acid, alkaline, oxidative, and photostability studies were performed for all three active ingredients.

Conclusion: This study demonstrated that a fast stability-indicating method has been developed for the simultaneous evaluation of amlodipine besylate, indapamide, and perindopril erbumine by RP-HPLC. The developed method has been successfully used for determining AMB, IND, and PRE in pharmaceutical dosage forms and their degradation products.

Keywords

Amlodipine besylate , Indapamide , Perindopril erbumine , RP-HPLC , Stability indicating method , Validation

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