TY  - JOUR
T1  - Fast Stability-Indicating HPLC Method for the Simultaneous Evaluation of Amlodipine Besylate, Indapamide, Perindopril Erbumine, and Their Degradation Products in Pharmaceutical Formulations
AU  - Demir, Filiz
AU  - Toker, Sıdıka
AU  - Ünlü, Serdar
PY  - 2025
DA  - September
Y2  - 2024
DO  - 10.26650/IstanbulJPharm.2025.1465651
JF  - İstanbul Journal of Pharmacy
JO  - iujp
PB  - Istanbul University
WT  - DergiPark
SN  - 2587-2087
SP  - 274
EP  - 281
VL  - 55
IS  - 2
LA  - en
AB  - 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.
KW  - Amlodipine besylate
KW  - Indapamide
KW  - Perindopril erbumine
KW  - RP-HPLC
KW  - Stability indicating method
KW  - Validation
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UR  - https://doi.org/10.26650/IstanbulJPharm.2025.1465651
L1  - https://dergipark.org.tr/en/download/article-file/3850555
ER  -