Stability Indicating RP-HPLC Method Development and Validation for the Quantification of Obeticholic Acid in Bulk and its Pharmaceutical Dosage Form

Indian Journal of Pharmaceutical Education and Research

  • R. Kiran Jyothi1Research Scholar, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
  • K.B. Chandrasekhar2Vice Chancellor, Krishna University, Machillipatnam, Andhra Pradesh, INDIA.
  • M. Balakrishnan3Principal, Sri Seshachala College of Pharmacy, Puttur, Andhra Pradesh, INDIA.
  • B. Siva Sai Kiran4Assistant Professor, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.

Volume 54 Issue 2s Pages s344-s349

DOI: 10.5530/ijper.54.2s.92

Abstract

Aim and Objectives: The aim of present research work is to develop stability indicating validated RP-HPLC method for the quantification of Obeticholic acid in bulk and its pharmaceutical dosage form. Materials and Methods: Chromatographic method was carried on C18 column (Ascentis 150mm x 4.6 mm, 5m). Mobile phase was prepared by mixing 0.1% OPA: Acetonitrile in the ratio of 60:40. The flow rate was 1.0 mL/min and the injection volume was 10 μL. The absorbance maxima of obeticholic acid was measured at 210 nm. The retention time was found to be 2.90 min. Results: The method was proved to be specific and linear in the range of 2.5 - 15 μg/mL with correlation coefficient of 0.999. The percentage RSD for precision was found to be less than 2 % and the mean percentage recovery was 100.08 %. All the validation parameters were statistically validated according to ICH guidelines and were found to be within acceptance criteria. Conclusion: The developed method was simple, specific, precise, accurate and robust. The described HPLC method can be successfully employed for the analysis of Obeticholic acid.

Keywords

  • Obeticholic acid
  • RP-HPLC method
  • 0.1% OPA
  • Acetonitrile
  • Validation
  • ICH
  • guidelines
IJOPP

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