Development And Validation Of Stability Indicating Hplc Method For Estimation Of Leuprolide Acetate In Its Parenteral Dosage Form
Keywords:
Leuprolide depot, Leutenising hormone-Releasing hormone, Stability indicating method, RP-HPLC, Forced degradationAbstract
In this study, A sensitive, accurate and cost effective RP-HPLC method was developed using YMC-Pack ODS-A(150mmX46mm), 3 µ stationary phase for quantitative determination of leuprolide acetate in its 3 month depot formulation. Chromatographic separation was achieved by using Mobile Phase A [Buffer (Triethylamine in milli Q water): Organic mixture (Acetonitrile: n-Propanol)(60:40)] and Mobile phase B (Buffer : Organic mixture)(50 : 50) by Gradient method under UV detection at 220 nm. Retention time was found to be 12 to 15 min. This drug was subjected to stress conditions like Acid, Alkali, Thermal, Photolytic and Humidity Degradation. Linearity was found to be in the range of 80-150 microgram/ml. The accuracy of present method was evaluated at 50%, 100% and 150%. The method was found to be robust. The method enables high throughput and is easy to perform.
Downloads
References
"ProstatCancer" National Cancer Institute. September 2017 https://training.seer.cancer.gov/prostate/intro/.
“Introduction to prostatcancer” september 2017 https://www.medicalnewstoday.com/articles/150086.php,
https://pubchem.ncbi.nlm.nih.gov/compound/Leuprolide_acetate section=Drug-and-Medication-Information, september ,2017.
https://www.drugbank.ca/drugs/DB00007 , September 2017.
Dr. S. Ravi Shankar, Textbook of Pharmaceutical Analysis, 3rd Edn, RX Publication, 2014, pp13.1, 13.3, 18.2 and 18.5.
Beckett A.H, and Stenlake J. B, Practical Pharmaceutical Chemistry, 1st Edn, CBS Publishers and Distributors New Delhi, 2004, pp 275-325.
Mishra S.,Patel C. J., Patel M.M. development and validation of stability indicating chromatographic method for simultaneous estimation of sacubitril and valsertan. International Journal of Applied Pharmaceutics. 2017;9 (5):1-8.
Stability Testing of New Drugs and Product:ICH Q1 A (R2). 2003, pp 1-20
European Pharmacopoeia 5.0, 2005, page no1898.
The United State Pharmacopoeial Convention, Pharmacopeial Forum :USP 37, pp-3514.
Pharamceuticals and Medical Devices Agency, Japanese Pharmacopoeia, XVII Edn; official mono-graph, page no 1150.
ICH Harmonized Tripartite Guideline; ?Stability testing: Photo stability testing of new drug sub-stances and products Q1B?; International Conference on Harmonization, IFPMA, Geneva, Switzer-land; 1996.
Sutherland j w,HPLC of Leuprolide Acetate in Injectable Solutions, Journal of Liquid Chromatogra-phy . 1987;10(10):2282-2289.
J.singh,Quantitation of leuprolide acetate by high performance liquid chromatograph”, Journal of Liquid Chromatography.2000;23(19):3023-3031.
Ahmad j.Stability-indicating HPTLC assay for leuprolide acetate. Journal of Planar Chromatography - Modern TLC . 2006;19(109):223-227.
Dong-seok lee,Development of new clean up method for UPLC-MS/MS analysis of leuprolide. journal of pharmaceutical investigation. 2016.
Sudarshan mantha,gopalvaidhyanathan, A Sensitive and rapid estimation of leuprolide in human plasma using UPLC and Xevo TQ-S, Waters Solution, pg 1-3.
X.Bao, Determination of leuprolide in beagle dogs’serum by high performance liquid chromatography-mass spectrometry and study on bioequivalence. Asian journal of chemistry. 2014 ;26(8):2322-2326.
Published
How to Cite
Issue
Section
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.
