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

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 ۲۱۵ nm as the determination wavelength. The drug was dissolved in NaOH solution (۰.۱N NaOH) for estimation in UV and in distilled water for the estimation in RP-HPLC using mobile phase ۰.۰۱ M Sodium dihydrogen phosphate (NaH۲PO۴): Acetonitrile (۸۰:۲۰), pH being adjusted to ۳.۳ with ۱۰% ortho-phosphoric acid. A linear response was observed in the range of ۱۰-۵۰ μg ml-۱ (R۲ = ۰.۹۹۸۱) for UV-Spectroscopy, whereas for RP-HPLC the linear response was observed in the range of ۲۰-۷۰ μg ml-۱ (R۲ = ۰.۹۹۶۵). The limits of quantitation (LOQ) were estimated as ۰.۱ μg ml-۱ and ۰.۰۵ μg ml-۱, respectively for UV and RP-HPLC respectively. The recoveries of IBN from the marketed formulation were found to be within ۱۰۰ ± ۲% 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 > ۰.۰۵) between UV and HPLC methods regarding validation parameters and assay content.

Keywords:

Ibandronate sodium (IBN) , UV-Vis spectroscopy , RP-HPLC , Calibration curve , LOD