A novel stability-indicating method for known and unknown impurities profiling for diltiazem hydrochloride pharmaceutical dosage form (tablets)

Abstract Background A novel gradient, high-sensitive and specific stability-indicating reverse-phase HPLC method was developed validated for quantitative purpose of known, unknown degradant impurities profiling diltiazem hydrochloride tablets. The were separated on the Zorbax RX C8 column (150 mm × 4.6 mm, 5 μm) with mobile phase-A consisting a mixture 0.05 M sodium dihydrogen phosphate monohydrate buffer pH 3.0 methanol in ratio 800:200v/v phase-B acetonitrile flow rate 1.0 mL min −1 . compartment maintained at 35 °C, detection wavelength 240 nm. Diltiazem hydrochloride, its known have been well resolved from each other. Results linearity has demonstrated across concentration range 0.18 to 5.65 µg EP impurity-F correlation coefficient R 2 greater than 0.99. Recovery proved LOQ 150% respect test found between 80 120%. Forced degradation study specificity experiment results mass balance nature all degradants other as main drug component (diltiazem hydrochloride). stress 95 105%. Conclusion Newly analytical per ICH Q2 (R1) guidelines “Validation procedure” linear, accurate, specific, robust precise established working range.