ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND METOPROLOL SUCCINATE IN BULK AND TABLET FORMULATION BY RP-HPLC METHOD

The present work involves a new method was established that is development and validation of RP-HPLC method for the estimation of cilnidipine and metoprolol succinate in their combination dosage form. In this HPLC method X-Terra C18 column (250 X4.6 mm ID) was used as SP and phosphate buffer, Acetonitrile in the ratio of 40: 60 as a MP was used. The flow rate was 1.2ml/min. & isobestic point of both drugs were quantified at 254 nm. The retention time for cilnidipine and metoprolol succinate was found to be 2.5mins and 10.5 mins respectively. The analytical method was validated according to ICH guidelines21 (ICH, Q2 (R1)). The linearity for Cilnidipine and Metoprolol Succinate was found in concentration range of 1-10µg/ml & 5-100µg/ml and Correlation coefficient (R2) value for both drugs was found to be 0.999, % recovery was found to be 99.6 to 100.00. RSD for method precision was 0.21& 0.11. Hence the suggested RP-HPLC method can be used for routine analysis of Cilnidipine and Metoprolol Succinate in API and Pharmaceutical dosage form.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-03-23
DOI
https://doi.org/10.5281/zenodo.15072663
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND METOPROLOL SUCCINATE IN BULK AND TABLET FORMULATION BY RP-HPLC METHOD

Zenodo (CERN European Organization for Nuclear Research)
Analytical Methods in Pharmaceuticals
article

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND METOPROLOL SUCCINATE IN BULK AND TABLET FORMULATION BY RP-HPLC METHOD

article en

Abstract

The present work involves a new method was established that is development and validation of RP-HPLC method for the estimation of cilnidipine and metoprolol succinate in their combination dosage form. In this HPLC method X-Terra C18 column (250 X4.6 mm ID) was used as SP and phosphate buffer, Acetonitrile in the ratio of 40: 60 as a MP was used. The flow rate was 1.2ml/min. & isobestic point of both drugs were quantified at 254 nm. The retention time for cilnidipine and metoprolol succinate was found to be 2.5mins and 10.5 mins respectively. The analytical method was validated according to ICH guidelines21 (ICH, Q2 (R1)). The linearity for Cilnidipine and Metoprolol Succinate was found in concentration range of 1-10µg/ml & 5-100µg/ml and Correlation coefficient (R2) value for both drugs was found to be 0.999, % recovery was found to be 99.6 to 100.00. RSD for method precision was 0.21& 0.11. Hence the suggested RP-HPLC method can be used for routine analysis of Cilnidipine and Metoprolol Succinate in API and Pharmaceutical dosage form.

Zenodo (CERN European Organization for Nuclear Research)
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Analytical Methods in Pharmaceuticals
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