A New Relıable And Rapıd Hplc Method For The Sımultaneous Determınatıon Of Amoxıcıllın And Sulbactam Pıvoxıl In Pharmaceutıcals. Applıcatıon To Both Assay And Dıssolutıon Samples

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Article Details

A New Relıable And Rapıd Hplc Method For The Sımultaneous Determınatıon Of Amoxıcıllın And Sulbactam Pıvoxıl In Pharmaceutıcals. Applıcatıon To Both Assay And Dıssolutıon Samples

Authors:

N.A.

Publisher:

Marmara University

Main Topics:

Pharmaceutical Sciences

Journal:

Journal of Research in Pharmacy Vol.26 Issue 1, pp.123-135

Document Type:

Article

Publication Date:

6/2025

Document Language:

English

Document ID (Org No.):

2001346110

pISSN:

2630-6344

Keywords:

Abstract:

 A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate AMO and sulbactam pivoxil SP in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water 80:20 vv in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 correlation coefficients higher than 0.9998. The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions AMOSP ratio between 1:1 and 7:1, being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMOSP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMOSP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.

 A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate AMO and sulbactam pivoxil SP in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water 80:20 vv in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 correlation coefficients higher than 0.9998. The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions AMOSP ratio between 1:1 and 7:1, being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMOSP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMOSP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.

 A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate AMO and sulbactam pivoxil SP in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water 80:20 vv in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 correlation coefficients higher than 0.9998. The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions AMOSP ratio between 1:1 and 7:1, being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMOSP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMOSP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.

 A fast, efficient and simple high performance liquid chromatographic method was developed and validated for the simultaneous determination of amoxicillin trihydrate AMO and sulbactam pivoxil SP in oral pharmaceutical dosage forms and, eventually, for their dissolution tests. The difference in molar absorptivities of these compounds constituted an analytical challenge, especially in formulations where AMO was in a higher proportion than SP. A reverse phase C18 column was used with a mobile phase consisting of acetonitrile and water 80:20 vv in isocratic mode. The retention times were found to be 2.26 min and 1.34 min for SP and AMO, respectively. The linearity range was evaluated over the concentration range of 2.5 and 250.0 µg mL-1 correlation coefficients higher than 0.9998. The method was validated according to the International Conference on Harmonization ICH guidelines regarding selectivity, linearity, accuracy, precision, limit of detection, limit of quantification, system suitability and robustness. The validated method was applied for the quantification of AMO and SP in commercial tablets and oral suspensions AMOSP ratio between 1:1 and 7:1, being the first method in the open literature that enables the correct quantification of both active ingredients in formulations with an AMOSP ratio higher than 1:1. Also, the new method was successfully applied for the dissolution study of AMOSP formulations, which was reported for the first time in the open literature. According to the obtained results, the proposed method can be applied in the quality control of pharmaceuticals containing a combination of amoxicillin and sulbactam pivoxil.

Article Details

A New Relıable And Rapıd Hplc Method For The Sımultaneous Determınatıon Of Amoxıcıllın And Sulbactam Pıvoxıl In Pharmaceutıcals. Applıcatıon To Both Assay And Dıssolutıon Samples

Authors:

N.A.

Publisher:

Marmara University

Main Topics:

Pharmaceutical Sciences

Journal:

Journal of Research in Pharmacy Vol.26 Issue 1, pp.123-135

Document Type:

Article

Publication Date:

6/2025

Document Language:

English

Document ID (Org No.):

2001346110

pISSN:

2630-6344

Amoxicillin trihydrate

sulbactam pivoxil

HPLC

method validation

dissolution

oral pharmaceutical dosage forms

Issues

Article Details

A New Relıable And Rapıd Hplc Method For The Sımultaneous Determınatıon Of Amoxıcıllın And Sulbactam Pıvoxıl In Pharmaceutıcals. Applıcatıon To Both Assay And Dıssolutıon Samples

Authors: N.A.

Publisher: Marmara University

Main Topics: Pharmaceutical Sciences

Journal: Journal of Research in Pharmacy Vol.26 Issue 1, pp.123-135

Document Type: Article

Publication Date: 6/2025

Document Language: English

Document ID (Org No.): 2001346110

pISSN: 2630-6344

Amoxicillin trihydrate

sulbactam pivoxil

HPLC

method validation

dissolution

oral pharmaceutical dosage forms

Issues

Authors:

N.A.

Publisher:

Marmara University

Main Topics:

Pharmaceutical Sciences

Journal:

Journal of Research in Pharmacy Vol.26 Issue 1, pp.123-135

Document Type:

Article

Publication Date:

6/2025

Document Language:

English

Document ID (Org No.):

2001346110

pISSN:

2630-6344