Open access · Peer reviewed · No APCs
Original ArticleIndian Journal of Pharmaceutical Education and ResearchVol. 54 | Issue 2s | 2020 | pp. s344–s349Open access
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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- 2,
- 3,
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- 1 Research Scholar, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
- 2 Vice Chancellor, Krishna University, Machillipatnam, Andhra Pradesh, INDIA.
- 3 Principal, Sri Seshachala College of Pharmacy, Puttur, Andhra Pradesh, INDIA.
- 4 Assistant Professor, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.
Published in Indian Journal of Pharmaceutical Education and Research
Correspondence: Email: jyothikiran460@gmail.com
Copyright: © 2020 Manuscript Technomedia. This is an open access article.
- Published:
- May 5, 2020
- Received:
- Sep 12, 2019
- Accepted:
- Feb 26, 2020
How to cite
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
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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Article metadata
| Title | Stability Indicating RP-HPLC Method Development and Validation for the Quantification of Obeticholic Acid in Bulk and its Pharmaceutical Dosage Form |
|---|---|
| Authors | R. Kiran Jyothi; K.B. Chandrasekhar; M. Balakrishnan; B. Siva Sai Kiran |
| Affiliations | Research Scholar, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA.; Vice Chancellor, Krishna University, Machillipatnam, Andhra Pradesh, INDIA.; Principal, Sri Seshachala College of Pharmacy, Puttur, Andhra Pradesh, INDIA.; Assistant Professor, Jawaharlal Nehru Technological University-Anantapur, Ananthapuramu, Andhra Pradesh, INDIA. |
| Corresponding author | jyothikiran460@gmail.com |
| Journal | Indian Journal of Pharmaceutical Education and Research |
| Volume / Issue | Vol. 54, Issue 2s (2020) |
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