STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF ZOLEDRONIC ACID IN INJECTABLES BY RP –HPLC

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Published: 2015-11-25

Page: 159-174


RAMADOSS KARTHIKEYAN *

Department of Pharmacognosy, Vignan Pharmacy College, Vadlamudi-522213, A. P, India

ORUGANTI SAI KOUSHIK

Department of Pharmacognosy, Vignan Pharmacy College, Vadlamudi-522213, A. P, India

P. SRINIVASA BABU

Department of Pharmaceutics, Vignan Pharmacy College, Vadlamudi-522213, A. P, India

*Author to whom correspondence should be addressed.


Abstract

The objective of present work is to develop a stability indicating high performance liquid chromatographic (HPLC) assay method for Zoledronic acid. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. In other stress conditions also the drug was found to be stable. Successful separation of the drug under stress conditions was achieved on a Zorbax c8(250 x 4.6), 5 µm column using a mixture of 10 mM solution of  Potassium dihydrogen orthophosphate (pH-3.2) methanol (95:5) as mobile phase. The flow rate was 0.7 mL/min and the analysis was performed using UV-Visible detector at 210 nm. The developed HPLC method is to assay the determination of Zoledronic acid and to determine related substances. It can be used to evaluate the quality of regular production samples.

Keywords: Zoledronic acid, HPLC, validation, forced degradation


How to Cite

KARTHIKEYAN, R., KOUSHIK, O. S., & BABU, P. S. (2015). STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF ZOLEDRONIC ACID IN INJECTABLES BY RP –HPLC. Journal of International Research in Medical and Pharmaceutical Sciences, 7(4), 159–174. Retrieved from https://ikprress.org/index.php/JIRMEPS/article/view/1881

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