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

Filiz Demir; Sıdıka Toker; Serdar Ünlü

Makale detayları

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

Yazarlar:

Filiz Demir | Sıdıka Toker | Serdar Ünlü

Yayıncı:

Istanbul University

Ana Başlıklar:

Pharmaceutical Analytical Chemistry

Dergi:

İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.274-281

Belge Tipi:

Makale

Yayın Tarihi:

9/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001353974

pISSN:

2587-2087

Anahtar kelimeler:

Özet:

 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 mLmin. The developed method was validated and then forced degradation studies were carried out according to the ICH guideline Q2R2 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 0.27740.8322, 0.0250.075, mgml and 0.08140.2442 mgml 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.

 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 mLmin. The developed method was validated and then forced degradation studies were carried out according to the ICH guideline Q2R2 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 0.27740.8322, 0.0250.075, mgml and 0.08140.2442 mgml 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.

 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 mLmin. The developed method was validated and then forced degradation studies were carried out according to the ICH guideline Q2R2 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 0.27740.8322, 0.0250.075, mgml and 0.08140.2442 mgml 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.

 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 mLmin. The developed method was validated and then forced degradation studies were carried out according to the ICH guideline Q2R2 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 0.27740.8322, 0.0250.075, mgml and 0.08140.2442 mgml 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.

Makale detayları

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

Yazarlar:

Filiz Demir | Sıdıka Toker | Serdar Ünlü

Yayıncı:

Istanbul University

Ana Başlıklar:

Pharmaceutical Analytical Chemistry

Dergi:

İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.274-281

Belge Tipi:

Makale

Yayın Tarihi:

9/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001353974

pISSN:

2587-2087

Amlodipine besylate

Indapamide

Perindopril erbumine

RP-HPLC

Stability indicating method

Validation

Sayı

Makale detayları

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

Yazarlar: Filiz Demir | Sıdıka Toker | Serdar Ünlü

Yayıncı: Istanbul University

Ana Başlıklar: Pharmaceutical Analytical Chemistry

Dergi: İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.274-281

Belge Tipi: Makale

Yayın Tarihi: 9/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001353974

pISSN: 2587-2087

Amlodipine besylate

Indapamide

Perindopril erbumine

RP-HPLC

Stability indicating method

Validation

Sayı

Yazarlar:

Filiz Demir | Sıdıka Toker | Serdar Ünlü

Yayıncı:

Istanbul University

Ana Başlıklar:

Pharmaceutical Analytical Chemistry

Dergi:

İstanbul Journal of Pharmacy Vol.55 Issue 2, pp.274-281

Belge Tipi:

Makale

Yayın Tarihi:

9/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001353974

pISSN:

2587-2087