Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination

N.A.

Makale detayları

Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Clinical Pharmacology and Therapeutics

Dergi:

Journal of Research in Pharmacy Vol.27 Issue 3, pp.1234-1241

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347912

pISSN:

2630-6344

Anahtar kelimeler:

Özet:

 A new HPLC method has been developed and validated with different parameters for the estimation of Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase of Methanol: 0.1  OPA in water 35:65 with a flow rate of 0.7 mlmin. C18 Column of 4.6 x 100 mm dimension was used as a stationary phase, particle size 5µm. The detection was carried out at 245 nm. The method was validated according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was found to be linear in a concentration range of 100-500 µgml for Metformin and 10-50 µgmL for Canagliflozin. The stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate, reproducible, and therefore suitable for routine analysis of drugs in a dosage form.

 A new HPLC method has been developed and validated with different parameters for the estimation of Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase of Methanol: 0.1  OPA in water 35:65 with a flow rate of 0.7 mlmin. C18 Column of 4.6 x 100 mm dimension was used as a stationary phase, particle size 5µm. The detection was carried out at 245 nm. The method was validated according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was found to be linear in a concentration range of 100-500 µgml for Metformin and 10-50 µgmL for Canagliflozin. The stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate, reproducible, and therefore suitable for routine analysis of drugs in a dosage form.

 A new HPLC method has been developed and validated with different parameters for the estimation of Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase of Methanol: 0.1  OPA in water 35:65 with a flow rate of 0.7 mlmin. C18 Column of 4.6 x 100 mm dimension was used as a stationary phase, particle size 5µm. The detection was carried out at 245 nm. The method was validated according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was found to be linear in a concentration range of 100-500 µgml for Metformin and 10-50 µgmL for Canagliflozin. The stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate, reproducible, and therefore suitable for routine analysis of drugs in a dosage form.

 A new HPLC method has been developed and validated with different parameters for the estimation of Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase of Methanol: 0.1  OPA in water 35:65 with a flow rate of 0.7 mlmin. C18 Column of 4.6 x 100 mm dimension was used as a stationary phase, particle size 5µm. The detection was carried out at 245 nm. The method was validated according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was found to be linear in a concentration range of 100-500 µgml for Metformin and 10-50 µgmL for Canagliflozin. The stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate, reproducible, and therefore suitable for routine analysis of drugs in a dosage form.

Makale detayları

Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Clinical Pharmacology and Therapeutics

Dergi:

Journal of Research in Pharmacy Vol.27 Issue 3, pp.1234-1241

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347912

pISSN:

2630-6344

HPLC

Method Development

Method Validation

Forced degradation

Canagliflozin

Metformin.

Sayı

Makale detayları

Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination

Yazarlar: N.A.

Yayıncı: Marmara University

Ana Başlıklar: Clinical Pharmacology and Therapeutics

Dergi: Journal of Research in Pharmacy Vol.27 Issue 3, pp.1234-1241

Belge Tipi: Makale

Yayın Tarihi: 6/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001347912

pISSN: 2630-6344

HPLC

Method Development

Method Validation

Forced degradation

Canagliflozin

Metformin.

Sayı

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Clinical Pharmacology and Therapeutics

Dergi:

Journal of Research in Pharmacy Vol.27 Issue 3, pp.1234-1241

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347912

pISSN:

2630-6344