Development And Validation of Rp-HPLC Method for The Estimation of Calcipotriene in Tablet Dosage Form

Wagdare Shivshankar Sidramappa; Malpani Surajmal Ganeshlal; Chandrawanshi Mayuri Jayprakash; Dharashive Vishweshwar Mahishankar

doi:10.69980/redvet.v25i1.1865

Wagdare Shivshankar Sidramappa
Malpani Surajmal Ganeshlal
Chandrawanshi Mayuri Jayprakash
Dharashive Vishweshwar Mahishankar

DOI: https://doi.org/10.69980/redvet.v25i1.1865

Keywords: High-Performance Liquid Chromatography, anti-cancer agent, Calcipotriene, ICH guidelines, linearity.

Abstract

This study presents the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the quantitative determination of Calcipotriene, an anti-cancer agent. The chromatographic separation was achieved using an Agilent C18 column (250 mm × 4.6 mm, 5 μm) with methanol and water (0.05% OPA, pH 3.5) in the ratio of 65:35 v/v as mobile phase at a flow rate of 0.7 ml/min. Detection was carried out at 264 nm with a retention time of approximately 6.8 minutes. The method was validated according to ICH guidelines, demonstrating linearity in the concentration range of 10-50 μg/ml with a correlation coefficient (r²) of 0.999 and linear regression equation y = 22.17x + 21.41. The developed method showed good resolution, symmetrical peak shape (symmetry factor 0.85), and theoretical plates (11465), indicating method efficiency. This simple, precise, and accurate analytical method can be effectively applied for routine analysis of Calcipotriene in pharmaceutical formulations.

Author Biographies

Wagdare Shivshankar Sidramappa

Department of Pharmaceutical Chemistry, Shivlingeshwar College of Pharmacy Almala, Maharashtra, India.

Malpani Surajmal Ganeshlal

Department of Pharmaceutical Chemistry, Shivlingeshwar College of Pharmacy Almala, Maharashtra, India.

Chandrawanshi Mayuri Jayprakash

Department of Pharmaceutics, Shivlingeshwar College of Pharmacy Almala, Maharashtra, India.

Dharashive Vishweshwar Mahishankar

Department of Pharmacology, Shivlingeshwar College of Pharmacy Almala, Maharashtra, India.

References

1. Skoog D.A., Holler F.J. and Nieman T.A., Principles of Instrumental Analysis, 5th ed., Thomson Brooks/Cole Asia Pvt. Ltd, Singapore, 2004, 4-7.
2. Lalitha N., Sanjay P.N., Vyshak M.G., Kadri U. and Trop. J. Pharma. Stability-indicating reverse phase HPLC method for the determination of cefazolin Res, 9(1), 2010, 45-50.
3. Willard R.H., Merritt L.L., Dean L.A., and Settle F.A., Instrumental Methods of analysis, 7,C.B.S. publishers, New Delhi, 1986, 177-178.
4. Skoog D.A., Holler F.J. and Nieman T.A., In Principles of Instrumental Analysis, 5, Thomson Brooks/Cole, 1998, 329-335.
5. Saint Louis, MO, ETATS-UNIS, International Symposium on High Performance Liquid Phase Separations and Related Techniques No 22, 1998, 828(1-2), 283-286.
6. Munson J.W., In; Pharmaceutical Analysis, Modern Methods, Part B, International Medical Book Distributors, Mumbai, 2001, 51-54.
7. http://www.chromatography-online.org/HPLC.html accessed on 12 February 2014 on 02:00pm .
8. Validation of Analytical Procedures: Methodology, ICH Harmonized Tripartite Guidelines, November1996, 1-8.
9. ICH, Q2A, Text on Validation of Analytical Procedures, International Conference on Harmonization, Geneva, October 1994, 1-5.
10. ICH, Q2B, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, Geneva, November 1996, 1-8.
11. www.drugbank.ca/drugs
12. https://www.rxlist.com/Calcipotriene.
13. http://en.wikipedia.org/wiki/Calcipotriene