Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and its Metabolite

Abstract

A novel stability indicating high performance liquid chromatographic assay method was developed and validated for Olmesartan medoxomil and its degradant product. An isocratic HPLC method was developed to separate the drug from the degradation products, using an Inertsil-ODS-3 (C-18) Column (5 µm, 250 mm × 4.60 mm). A mixture of phosphate buffer (pH 4.0) and methanol (30:70) was used as mobile phase. The flow rate was 1.0 mL/min and the detection was carried out at 230 nm. The validation studies were carried out fulfilling the International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate, and robust.

Keywords:

• HPLC
• LC-MS/MS
• Olmesartan medoxomil
• Stability indicating assay method

ACKNOWLEDGMENTS

We wish thank to Sophisticated Analytical Instruments Facility, Indian Institute of Technology, Mumbai for providing us LC-MS/MS facility. We would like to thank Glenmark Pharmaceuticals Ltd. (Mumbai, India) for providing gift samples of Olmesartan medoxomil.

Notes

^a S.D. = Standard deviation.

^b R.S.D. = Relative standard deviation.

^c n = Number of determination.

^a S.D. = Standard deviation.

^b R.S.D. = Relative standard deviation.

^c n = Number of determination.

^a S.D. = Standard deviation.

^b R.S.D. = Relative standard deviation.

^c n = Number of determination.

^a S.D. = Standard deviation.

^b R.S.D. = Relative standard deviation.

^c n = Number of determination.