Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Dobarıya Hıteksha

Makale detayları

Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Yazarlar:

Dobarıya Hıteksha

Yayıncı:

Turkish Chemical Society

Ana Başlıklar:

Analytical Chemistry

Dergi:

Journal of the Turkish Chemical Society Section A: Chemistry Vol.10 Issue 4, pp.1025-1034

Belge Tipi:

Makale

Yayın Tarihi:

11/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001294235

pISSN:

2149-0120

Anahtar kelimeler:

Özet:

 For the quantitative measurement of Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate in synthetic mixture form in the presence of its degradants, precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises Methanol: 20 mM Ammonium formate 70:30 vv at a flow rate of 1.0 mlmin, injection volume of 20 µl, and UV detection at 225 nm. Separation was accomplished using Gemini, C18 column. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate were eluted with retention times of 6.65 minutes and 4.20 minutes, respectively. This procedure was approved following ICH guideline Q2 R1. The calibration plots for Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate have correlation coefficients of 0.9995 and 0.9996 over the concentration ranges of 5-100 µgml and 10-200 µgml respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, accuracy ranged from 99.81-100.78 and 99.13-100.69, respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, the LOD was found to be 0.947 µgml and 1.355 µgml. In contrast, the LOQ was 2.869 µgml and 4.107 µgml, respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants.

 For the quantitative measurement of Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate in synthetic mixture form in the presence of its degradants, precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises Methanol: 20 mM Ammonium formate 70:30 vv at a flow rate of 1.0 mlmin, injection volume of 20 µl, and UV detection at 225 nm. Separation was accomplished using Gemini, C18 column. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate were eluted with retention times of 6.65 minutes and 4.20 minutes, respectively. This procedure was approved following ICH guideline Q2 R1. The calibration plots for Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate have correlation coefficients of 0.9995 and 0.9996 over the concentration ranges of 5-100 µgml and 10-200 µgml respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, accuracy ranged from 99.81-100.78 and 99.13-100.69, respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, the LOD was found to be 0.947 µgml and 1.355 µgml. In contrast, the LOQ was 2.869 µgml and 4.107 µgml, respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants.

 For the quantitative measurement of Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate in synthetic mixture form in the presence of its degradants, precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises Methanol: 20 mM Ammonium formate 70:30 vv at a flow rate of 1.0 mlmin, injection volume of 20 µl, and UV detection at 225 nm. Separation was accomplished using Gemini, C18 column. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate were eluted with retention times of 6.65 minutes and 4.20 minutes, respectively. This procedure was approved following ICH guideline Q2 R1. The calibration plots for Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate have correlation coefficients of 0.9995 and 0.9996 over the concentration ranges of 5-100 µgml and 10-200 µgml respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, accuracy ranged from 99.81-100.78 and 99.13-100.69, respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, the LOD was found to be 0.947 µgml and 1.355 µgml. In contrast, the LOQ was 2.869 µgml and 4.107 µgml, respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants.

 For the quantitative measurement of Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate in synthetic mixture form in the presence of its degradants, precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises Methanol: 20 mM Ammonium formate 70:30 vv at a flow rate of 1.0 mlmin, injection volume of 20 µl, and UV detection at 225 nm. Separation was accomplished using Gemini, C18 column. Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate were eluted with retention times of 6.65 minutes and 4.20 minutes, respectively. This procedure was approved following ICH guideline Q2 R1. The calibration plots for Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate have correlation coefficients of 0.9995 and 0.9996 over the concentration ranges of 5-100 µgml and 10-200 µgml respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, accuracy ranged from 99.81-100.78 and 99.13-100.69, respectively. For Dapagliflozin propanediol monohydrate and Teneligliptin hydrobromide hydrate, the LOD was found to be 0.947 µgml and 1.355 µgml. In contrast, the LOQ was 2.869 µgml and 4.107 µgml, respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide hydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants.

Makale detayları

Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Yazarlar:

Dobarıya Hıteksha

Yayıncı:

Turkish Chemical Society

Ana Başlıklar:

Analytical Chemistry

Dergi:

Journal of the Turkish Chemical Society Section A: Chemistry Vol.10 Issue 4, pp.1025-1034

Belge Tipi:

Makale

Yayın Tarihi:

11/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001294235

pISSN:

2149-0120

Dapagliflozin propanediol monohydrate

Teneligliptin hydrobromide hydrate

RP- HPLC

Stability indicating method

Validation

Sayı

Makale detayları

Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Yazarlar: Dobarıya Hıteksha

Yayıncı: Turkish Chemical Society

Ana Başlıklar: Analytical Chemistry

Dergi: Journal of the Turkish Chemical Society Section A: Chemistry Vol.10 Issue 4, pp.1025-1034

Belge Tipi: Makale

Yayın Tarihi: 11/2023

Belge Dili: İngilizce

Document ID (Org No.): 2001294235

pISSN: 2149-0120

Dapagliflozin propanediol monohydrate

Teneligliptin hydrobromide hydrate

RP- HPLC

Stability indicating method

Validation

Sayı

Yazarlar:

Dobarıya Hıteksha

Yayıncı:

Turkish Chemical Society

Ana Başlıklar:

Analytical Chemistry

Dergi:

Journal of the Turkish Chemical Society Section A: Chemistry Vol.10 Issue 4, pp.1025-1034

Belge Tipi:

Makale

Yayın Tarihi:

11/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001294235

pISSN:

2149-0120