Development and Validation of UV Spectrophotometric Method for Estimation Ibandronate sodium in Pharmaceutical Formulation

  • Prajakta A. Chawale Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016
  • Dinesh R. Chaple Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016
  • Alpana J. Asnani Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016
  • Kumar Pratyush Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Abstract

A simple, accurate, precise, rapid spectrophotometric method for estimation of Ibandronate sodium in pharmaceutical formulation. Ibandronate sodium is one off the nitrogen carrying bisphosphonate. It prevents osteoclast-conciliate bone resorption, Paget’s disease, postmenopausal osteoporosis. The maximum wavelength (λmax) of ibandronate sodium is 218nm. Linearity was observed in the concentration range 2-100µg/ml. The coefficient of variation value was found to be 0.3499. Amount of drug estimated from tablet formulation were in precise with label claim. The method was statistically validated as per ICH guidelines and can be successively applied for analysis for tablet formulation. The proposed method is economical and sensitive for estimation of ibandronate sodium in pharmaceutical formulation.


Keywords-Ibandronate sodium, ICH guidelines, Bisphosphonate, pharmaceutical formulation.

Downloads

Download data is not yet available.

Author Biographies

Prajakta A. Chawale, Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Dinesh R. Chaple, Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Alpana J. Asnani, Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Kumar Pratyush, Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

Priyadarshini J. L. College of Pharmacy, Electronic zone, Electronic building, Hingna Road, Nagpur-440016

References

1. Chatwal G R, Pharmaceutical Organic Chemistry, 5th ed, Himalaya Publishing House, 2002, p.125-124.
2. Skoog A.D, Fundamentals of Analytical Chemistry, 8th Ed, Thomson brook/Cole, 2004, p.1-16.
3. Jeffery G.H, et al, Vogel’s text book of Quantitative Chemical Analysis,5th Ed, Congmon Scientific and Technical, 1999, p.10-26.
4. Kaur H, Spectroscopy, 5th Ed, Pragati Prakashan, Meerut, 2010, p.65-82.
5. FDA, Guidance for Industry: Analytical Procedures and Methods Validation (Draft guidance), Food and Drug Administration, Rockville, MD., 2000, p.501-505.
6. ICH, Stability Testing of New Drug Substances and Products, Q1A(R2), Geneva, International Conference on Harmonization, 2003, p.462-489.
7. Siddiqui Anees A. Pharmaceutical Analysis. 2nd ed, CBS Publishers and Distributors pvt. ltd., 2009, p. 52-53.
8. Kasture A. V, Wadodkar, et al, Pharmaceutical Analysis, Nirali Prakashan, 2010, p.4-6.
9. Dr. Sethi P. D, High Performance Liquid Chromatography (Quantitative Analysis of Pharmaceutical Formulation), 1st Ed, CBS Publisher and Distributors, 2001, p. 6-7
10. Indian Pharmacopoeia, Government of India Ministry of Health and Family Welfare, Vol 2, The Indian Pharmacopoeia Commission Ghaziabad, 2007, p. 749-756.
11. The Merck Index, 14th Ed, Merck Research Laboratories, 2006, p.142a, 942b.
12. Jineetkumar B. Gawad, Development and Validation of RP-HPLC assay method for determination of Ibandronate sodium in tablet dosage form. International Journal of Innovative Pharmaceutical Research 2012; (3):220-225.
13. Lubna Azmi., A Straightforward and Receptive UV Spectrophotometric Method for the determination of Ibandronate sodium in Pharmaceutical Formulations and Bulk drugs. Journal of Advances in Medical and Pharmaceutical Sciences 2016; (6):1-7.
14. Hemant Kumar Sharma., Stability indicating ion chromatography method for the simultaneous determination of Ibandronate sodium drug substance and its impurities. Journal of Pharmaceutical and Biomedical Analysis. 2011; (54):596-601.
15. Frieder Bauss., Analytical methods for the quantification of Ibandronate in body fluids and bone. 2005; (39):246-256.
16. Jineetkumar B. Gawad, Development and Validation of RP-HPLC Dissolution method for determination of Ibandronate sodium in Tablet dosage form. World Journal of Pharmacy and Pharmaceutical sciences. 2013; (3):287-301.
17. Oliver WAHL, Impurity profiling of Ibandronate sodium by HPLC-CAD. Journal of pharmaceutical and Biomedical analysis. 2015; (1):1-5.
18. Acharya S, A Validated HPLC method for determination of Ibandronate sodium residue in cleaning pharmaceutical equipment by refractive index detector. Analytical Chemistry: An Indian Journal. 2011; (1):1-6.
19. L.E. Diaz., validation of a Capillary electrophoresis method for the analysis of Ibandronate related impurities. Journal of pharmaceutical and Biomedical analysis. 2007; (44):305-308.
20. Bhusari S., Chaudhari T., Wakte P. Development and validation of a spectrofluorimetric method for the estimation of camptothecin in bulk and formulation. Journal of Drug Delivery and Therapeutics, 2019; 9(2-s):1-5.
https://doi.org/10.22270/jddt.v9i2-s.2586
Statistics
1 Views | 6 Downloads
How to Cite
Chawale, P. A., Chaple, D. R., Asnani, A. J., & Pratyush, K. (2019). Development and Validation of UV Spectrophotometric Method for Estimation Ibandronate sodium in Pharmaceutical Formulation. Journal of Drug Delivery and Therapeutics, 9(3), 339-343. https://doi.org/10.22270/jddt.v9i3.2675