Method development and validation of Nicardipine Hydrochloride injection and its related substances by RP-HPLC

Method development and validation of Nicardipine Hydrochloride injection and its related substances by RP-HPLC P Shanmugasundaram

For the estimation and validation of related substances in nicardipine hydrochloride, such as nicardipine monoacids, nicardipine dehydroxy, nicardipine pyridine analog, nicardipine bis analog, and nicardipine dimethyl ester, which exhibits maximum absorbance at 239 nm, an RP- HPLC is a straightforward, accurate, and dependable diode array detector. The purpose of this research is to identify the related impurities present in the nicardipine hydrochloride injection and to identify whether they are complies under unites states food and drug administration guidelines. The calcium channel blocker nicardipine hydrochloride was separated using Inertsil ODS 3V 4.6*250, 5 µm. Four parts methanol and six parts potassium dihydrogen phosphate buffers make up the mobile phase. The isocratic elution mode was used to execute the chromatographic condition at a flow rate of 0.8 ml/min. The method has been validated for LOD and Precision at the LOQ level, accuracy, linearity, method precision, specificity, robustness, and forced degradation tests, in accordance with food and drug administration requirements. For nicardipine hydrochloride, the calibration curve was linear between 4 and 24 µg/ml and correlation coefficient was found to be 0.9997. The forced degradation studies shows that the mass balance was found to be 89.5, respectively. The estimation and validation of nicardipine hydrochloride injection was performed effectively by HPLC using the suggested method.
06 15 2024 06 22 2024 385 398 10.48047/AFJBS.6.3.2024.385-398 https://www.afjbs.com/uploads/paper/8dbff704a72288107b05cc1a4eb36925.pdf