Determination of Nimodipine Stability by UV-Spectroscopy along with Quantum Mechanics to Establish Method, Validation, and Force Degradation Study

Nimodipine is a Calcium Channel Blocker (CCB) used to treat high blood pressure. CCB worked as an antihypertensive drug. In this study, Nimodipine is used as a CCB to study spectral behavior by spectrophotometric method and further validated by computational methods to correlate with theoretical aspects. It is subjected to stress conditions by applying varying forced degradation parameters including temperature, photolytic, oxidative, acidic, and basic conditions to find the stability of the drug and predict the chemical reactions that take place during degradation. The other parameters including order of reaction, shelf-life, half-life, and their energy of activation are determined. The method validation of a drug is performed according to the International Conference on Harmonization (ICH) guidelines by using parameters i.e. Linearity/ Range, Limit of Detection (LOD), Limit of Quantitation (LOQ), Stability, Accuracy, Precision, Robustness, and Ruggedness. It is observed that the developed method using UV-spectroscopy can be considered a sensitive and fast reproducible method for the determination of Nimodipine. In the degradation study, it is observed that Nimodipine is thermally stable, and in the case of acidic, basic, and oxidative degradation, the reaction followed first-order kinetics whereas zeroth-order kinetics is observed in photolytic degradation. The recovery time of ۱۰% and ۵۰% drug degradation are also calculated. In the validation study, the range of linearity is observed between ۲.۵ to ۴۰ μg/mL. The LOD and LOQ are calculated and it is found ۰.۱۴۲۲ μg/mL and ۰.۴۲۷۰ μg/mL in acidic medium and ۰.۱۱۸۴ μg/mL and ۰.۳۵۹۰ μg/mL in basic medium. Stability, inter-day precision, intra-day precision, robustness, and ruggedness are calculated and results are within the acceptance criteria. This method can be employed to analyze any calcium channel blockers by slight modification. For a better understanding of CCB, the following perspective can be adopted in the future.

کلیدواژه ها:

Nimodipine ، Calcium Channel Blocker (CCB) ، UV-Vis spectrophotometry ، Quantum Mechanics ، forced degradation ، robustness and ruggedness