Stability Indicating Spectrophotometric Methods Determination of Nicardipine in the Presence of its Alkaline Induced Degradation Products
Abstract
Objective: Derivative, ratio spectra derivative and ratio difference spectrophotometric methods were developed and validated for simultaneous determination of Nicardipine (NIC) in the presence of its alkaline induced degradation products.
Methods: In these methods the overlapped spectra of NIC and its alkaline induced degradation products were well resolved by measuring the amplitudes of first derivative (D1) spectra and the second derivative (D2) at 382.3 and 239 nm, respectively. NIC was determined by ratio spectra derivative by measuring the amplitude at 244 nm. The ratio difference spectrophotometric method was developed in which the difference between amplitudes at 237.5 nm and 260 nm of the ratio spectra were recorded. The linearity range for the applied methods was 2-18 μg/ml.
Results: All the developed methods were validated according to ICH Guidelines, NIC was determined with acceptable accuracy and precision.
Conclusion: These methods were suitable as stability indicating methods for the determination of NIC in the presence of its alkaline induced degradation products either in bulk powder or in a pharmaceutical formulation. Statistical analysis of the results with those obtained by applying a reported method has been carried out revealing high accuracy and good precision.
Keywords: Nicardipine, Spectrophotometry, Pharmaceutical preparations, Stability indicating, derivative, ratio derivative and ratio difference
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References
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