Development and validation of stability indicating assay method for cinitapride in bulk and tablets

ABSTRACT

A simple stability indicating UV-spectrophotometric method has been developed and validated for the determination of cinitapride hydrogen tartrate [CHT] in bulk and solid pharmaceutical dosage form. Drug absorption was measured in different analytical mediums however; maximum absorption was seen in 0.1 N HCl at wavelength [lamda [max]] of 266 nm. The calibration curve was found to be linear over the concentration range from 6 to14 micro g/mL with the correlation coefficient value [r] of 0.999. The LOD and LOQ were estimated to be 0.1019 micro g/ml and 0.309 micro g/ml respectively. The accuracy was evaluated by determining the percent drug recovery, performed at three different levels of 50%, 100% and 150%. The% recovery was found to be in the range of 99.96-100.64%. The precision of the method was determined by inter-day and intra-day variations. The % RSD value <0.5 indicates the underlying method is precise and accurate as well. The developed method was applied to characterize in vitro assay content of few brands of cinitapride [1 mg] available in local market. No interference of the formulation excipients with the drug absorption was observed during assay. Drug substance and drug product were exposed to various stressed conditions [acid, base, oxidative, thermal and photolysis]. Forced degradation testing of drug product showed that the oxidation [20%] was found to be the major degradation pathway of the cinitapride. However; drug estimation was not influenced in presence of degradation moieties formed during acid, base, oxidation, thermal and photolytic breakdown. Overall, the investigated technique is robust and specific that would be successfully used to quantify the cinitapride hydrogen tartarate in pharmaceutical dosage and bulk form in future