“Development Of A Quantitative Method For The Assessment Of (S)-Amlodipine Di-P-Toluoyl-D-Tartaric Acid”

  • Abhijit Desai
  • Kalpana Patankar-Jain
Keywords: Method validation, linearity, accuracy, precision, inter-assays precision

Abstract

A reverse-phase high-performance liquid chromatography (RP HPLC) method was developed and validated for the analysis of (S)-amlodipine di-p-toluoyl-D-tartaric acid. The analysis used a mobile phase of acetonitrile and water (80:20 v/v) at a flow rate of 0.8 ml/min, with UV detection at 249 nm, and was performed on a HYPERSIL column (250 x 4.6 mm, 5 µm). The retention time for (S)-amlodipine di-p-toluoyl-D-tartaric acid was 5.742 minutes. The method demonstrated a linear response for concentrations ranging from 4 to 24 ppm, with a correlation coefficient ('r' value) of 0.999. The method's linearity, accuracy, precision, selectivity, robustness, and forced degradation studies were thoroughly evaluated, meeting all the criteria set by ICH guidelines. Intra- and inter-day precision showed relative standard deviations below 2%. The percentage recoveries of (S)-amlodipine di-p-toluoyl-D-tartaric acid in pharmaceutical formulations were between 98.74% and 101.11%, with an overall mean recovery of 99.59%.

Author Biographies

Abhijit Desai

Sonopant Dandekar Arts, VS Apte Commerce & MH Mehta Science College, Palghar(W), Maharashtra

Kalpana Patankar-Jain

Dept of Chem, Royal College of Arts, Science, Commerce and Management, Mira Bhayandar, Maharashtra

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Published
2024-10-04
How to Cite
Abhijit Desai, & Kalpana Patankar-Jain. (2024). “Development Of A Quantitative Method For The Assessment Of (S)-Amlodipine Di-P-Toluoyl-D-Tartaric Acid”. Revista Electronica De Veterinaria, 25(1), 2178-2184. https://doi.org/10.69980/redvet.v25i1.1112
Section
Articles