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

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Article · Volume 54, Issue 2s (Supplement) · pp. s344-s349

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

R. Kiran Jyothi1, K.B. Chandrasekhar2, M. Balakrishnan3, B. Siva Sai Kiran4

  1. 1Research Scholar, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
  2. 2Vice Chancellor, Krishna University, Machillipatnam, Andhra Pradesh, INDIA.
  3. 3Principal, Sri Seshachala College of Pharmacy, Puttur, Andhra Pradesh, INDIA.
  4. 4Assistant Professor, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.

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

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