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Vol. 35 No. 8 (2023): Vol 35 Issue 8, 2023

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Eco-friendly RP-HPLC UV Quantification Method for Parental Products Buffer Agents by Utilizing Polymethacrylate Resin Stationary Phase in Light of Quality by Design

https://doi.org/10.14233/ajchem.2023.28038
Lankella Sasikala
Department of Chemistry, Government Degree College, Falaknuma-500053, India Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Rudraram, Sangareddy-502329, India
https://orcid.org/0009-0007-1406-9892
Vandavasi Koteswara Rao
Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Rudraram, Sangareddy-502329, India
https://orcid.org/0000-0003-4737-4571
Naresh Kumar Katari
Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Rudraram, Sangareddy-502329, India
https://orcid.org/0000-0002-5737-8528
Leela Prasad Kowtharapu
Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Rudraram, Sangareddy-502329, India
https://orcid.org/0000-0003-1199-2458
Rathnakar Nathi
Analytical Development Department, Shenzhen DEC Pharmaceutical Co., Ltd, Shenzhen 518000, China
https://orcid.org/0000-0002-8912-5736

Corresponding Author(s) : Leela Prasad Kowtharapu

leelaprasadkowtharapu@gmail.com

Asian Journal of Chemistry, Vol. 35 No. 8 (2023): Vol 35 Issue 8, 2023

Abstract

Parental products buffer agents viz. calcium phosphate (CP), potassium phosphate (PP) and sodium phosphate (SP) were successfully qualitatively and quantitatively determined on RP-HPLC in the UV detection. The three components were retained in reverse phase by utilizing polymethacrylate resin stationary phase. The quantification was done by using the waters IC-Pak (50 × 4.6) mm, 10 μm column with 1.0 mL/min flow rate. 0.1 M nitric acid solution was used as a mobile phase. The detection was done at 288 nm, column temperature was 30 ºC, injection volume was 50 μL and the total run time was 5 min. The method was validated as per the regulatory and ICH guidelines. The accuracy was found from 98.5% to 101.5% and the precision data was found from 0.5% to 0.9%. The linearity resulted in r value more than 0.999. Quality by design software was used to establish the method robustness. Green chemistry principles and tools were used to assess the method eco-ness. The developed method can be utilized as an application to quantify the buffer agent content in selected parental products.

Keywords

Calcium phosphate Potassium phosphate Sodium phosphate QbD Analytical eco-scale
Sasikala, L., Rao, V. K., Katari, N. K., Kowtharapu, L. P., & Nathi, R. (2023). Eco-friendly RP-HPLC UV Quantification Method for Parental Products Buffer Agents by Utilizing Polymethacrylate Resin Stationary Phase in Light of Quality by Design. Asian Journal of Chemistry, 35(8), 1843–1849. https://doi.org/10.14233/ajchem.2023.28038
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