VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF RALOXIFENE (ANTI-OSTEOPOROTIC AGENT) IN TABLETS
Abstract
Raloxifene hydrochloride is a new anti-osteoporotic agent, effective in the treatment of breast cancer. A stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Raloxifene Hydrochloride in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model LC-20AD Prominence with SPD M 20A Diode array detector using a Phenomenex Lichrosphere 100 C-18 (250 mm × 4.6 mm i.d., 5 µm particle size) column with sodium acetate: methanol (40:60, V/V) as mobile phase with a flow rate of 1 ml/min. UV detection was performed at 287 nm. Linearity was observed in the concentration range of 1.0–250 μg/mL with regression equation y = 95604 x – 26215 with correlation coefficient of 0.9999. The LOD and LOQ were found to be 0.267 μg/mL and 0.813 μg/mL respectively. The percentage relative standard deviation in precision and accuracy studies was found to be less than 2%. Raloxifene hydrochloride was subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation and photolysis. It was found that the drug is highly resistant towards all degradations as the decomposition was less than 3.5%. The developed method was validated with regard to linearity, accuracy, precision, selectivity and robustness and the method was found to be precise, accurate, linear and specific.
Keywords: Raloxifene hydrochloride, Isocratic elution, RP-HPLC, Validation, Stability-indicating, LOD, LOQ.
DOI
https://doi.org/10.22270/jddt.v2i4.257
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