Simultaneous RP-HPLC and UV Spectroscopic Method Development and Validation for Estimation of Ibandronate Sodium in Bulk and Pharmaceutical Dosage Form

Document Type : Research Paper

Authors

1 Dr. B.C. Roy College of Pharmacy & AHS

2 WBUT

3 Sigma Institute of Pharmacy

Abstract

The present study describes a simple, accurate, precise and cost effective UV-Vis Spectroscopic and RP-HPLC method for the estimation of Ibandronate sodium (IBN). The determination of Ibandronate sodium (IBN) was performed by both UV and RP-HPLC method using 215 nm as the determination wavelength. The drug was dissolved in NaOH solution (0.1N NaOH) for estimation in UV and in distilled water for the estimation in RP-HPLC using mobile phase 0.01 M Sodium dihydrogen phosphate (NaH2PO4): Acetonitrile (80:20), pH being adjusted to 3.3 with 10% ortho-phosphoric acid. A linear response was observed in the range of 10-50 μg ml-1 (R2 = 0.9981) for UV-Spectroscopy, whereas for RP-HPLC the linear response was observed in the range of 20-70 μg ml-1 (R2 = 0.9965). The limits of quantitation (LOQ) were estimated as 0.1 μg ml-1 and 0.05 μg ml-1, respectively for UV and RP-HPLC respectively. The recoveries of IBN from the marketed formulation were found to be within 100 ± 2% by both the methods. These methods were then effectively applied for the estimation of Boniva (tablet) and the results were obtained according to nominal content. The statistical analysis revealed that there is no significant difference (p > 0.05) between UV and HPLC methods regarding validation parameters and assay content.

Keywords


[1] F. Bauss, S. Lalla, R. Endele, LA. Hothorn, J. Rheumatol., 29 (2002), 2200–2208.
[2] F. Bauss and RR Graham, Osteoporos Int., 15 (2004), 423–433.
[3] MJ. Lovdahl, DJ. Pietrzyk, J. Chromatogr A., 868 (2000), 141–142.
[4] H. My, Z. Xq, W. Bc, Se Pu, 18 (2000), 18, 254–255.
[5] JAB. Rodriguez, MF. Desimone, SL. Iglesias, SL. Giorgieri, LE. Diaz, J. Pharm. Biomed. Anal., 44 (2007), 305–308.
[6] Y. Xie Z. Jiang, Chromatogr, 62 (2005), 257–261.
[7] M. Narendra Kumar, K.S.R. Pavan Kumar, Vundavilli Jagadeesh Kumar, S. John Prasanna, Hemant Kumar Sharma, V. Krishna Reddy, J. Pharm. Biomed. Anal., 54 (2011) 596–601.
[8] B. Jineet kumar Gawad, S. Pritam Jain, International Journal of Innovative Pharmaceutical Research. 3 (2012), 220-225
[9] B. Jineet kumar Gawad, S. Pritam Jain, B. Sanjay Bari, International Journal of Chem Tech Research, 5 (2013), 1733-1743.
[10] ICH: Guideline on the Validation of Analytical Procedures: Methodology, 62 (96), 19th May 1997.
[11] International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline, Validation of analytical procedures: text and method Q2 (R1), step 4 2005.