Stability Indicating RP-HPLC Method Development and Validation for the Quantification of Obeticholic Acid in Bulk and its Pharmaceutical Dosage Form
1, 2, 3, 4
- 1Research Scholar, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
- 2Vice Chancellor, Krishna University, Machillipatnam, Andhra Pradesh, INDIA.
- 3Principal, Sri Seshachala College of Pharmacy, Puttur, Andhra Pradesh, INDIA.
- 4Assistant Professor, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
CORRESPONDENCE
R. Kiran Jyothi
Research Scholar, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
Received: 12-09-2019; Accepted: 26-02-2020.
Volume 54, Issue 2s (Supplement) · pp. s344-s349 · 2020 · 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.
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Jyothi, R. K., Chandrasekhar, K., Balakrishnan, M., & Kiran, B. S. S. (2020). 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, 54(2s), s344-s349. https://doi.org/10.5530/ijper.54.2s.92
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