Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

1. Reginster JY, Brandi ML, Cannata-Andía J et al - The position of strontium ranelate in today’s management of osteoporosis. Osteoporos Int. 2015;26:1667-7110.1007/s00198-015-3109-y25868510Search in Google Scholar

2. EMEA, European Medicines Agency, Osseor, Scientific Discussion, London 2005; http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000561/WC500051099.pdf; last access date: May 10, 2018Search in Google Scholar

3. Mythili K, Gayatri S, Kumar EM, et al - Development and validation of UV spectrophotometric method for the estimation of strontium ranelate in sachet formulation. Research Journal of Pharmacy and Technology. 2011;4:1468-70Search in Google Scholar

4. Swami AS, Pishawikar AS, More HN - UV-spectrophotometric method development and validation for estimation of strontium ranelate in bulk. International Journal of Pharma and Bio Sciences. 2012;3: 171-76Search in Google Scholar

5. Rizk M, El-Alamin MMA, Moawad MI - A simple kinetic spectrophotometric method for determination of strontium ranelate in bulk and pharmaceutical dosage form. Indo American Journal of Pharmaceutical Research. 2015;5:2503-12Search in Google Scholar

6. Chavan DS, Pishawikar SA, More HN et al - Validated Spectrophotometric Method Development for Strontium Ranelate from Newly Developed Floating Tablet Formulation. International Journal of Science and Research. 2018;7:634-37Search in Google Scholar

7. Swami AS, Pishawikar AS, More HN - Forced degradation study of strontium ranelate (anti-osteoporotic drug). International Journal of Pharmaceutical Sciences Review and Research; 2012, 12(2): 22-6Search in Google Scholar

8. Reddy BRCS, Rao NVB - A validated stability indicating RP-HPLC method for the determination of strontium ranelate a dual acting bone agent in bulk and sachet dosage form. Rasayan Journal of Chemistry. 2014;7:20-7Search in Google Scholar

9. Kovács B, Kántor LK, Croitoru MD et al - Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design. Acta Pharm. 2018;68:171-8310.2478/acph-2018-001929702478Search in Google Scholar

10. Mythili K, Gayatri S, Teja KR, et al - Development and validation of RP-HPLC method for the estimation of strontium ranelate in sachet. International Journal of Pharma and Bio Sciences. 2011;2:258-63Search in Google Scholar

11. de Carvalho RC, Netto ADP, de Carvalho Marques FF - Simultaneous determination of strontium ranelate and aspartame in pharmaceutical formulation for the treatment of postmenopausal osteoporosis by capillary zone electrophoresis. Microchemical Journal. 2014;117:214-1910.1016/j.microc.2014.06.024Search in Google Scholar

12. ICH International Conference on Harmonization, Harmonized Tripartite Guideline – Stability testing of New Drug Products Q1A (R2), Step 4, 2003; https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf; accessed on: 30th of August 2018Search in Google Scholar

13. ICH Harmonized Tripartite Guideline – Stability testing: Photostability of New Drug Substances and Products Q1B, Step 4, 1996é https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1B/Step4/Q1B_Guideline.pdf; accessed on: 30th of August 2018Search in Google Scholar