Analytical Method Development, Validation and Solubility Estimation of Nicardipine HCL in Various Oil Solvents, Surfactants and Cosurfactants

Abstract

Objective: This study is focused on the development of an analytical method and the evaluation of the solubility of Nicardipine HCl (NHCL) in various oil solvents, surfactants, and cosurfactants using the saturated solubility determination method employing UV Spectrophotometry. Methods: Lipophilic solvents such as Caprylic Capric, Soyabean oil, linseed oil, Coconut oil, Sunflower oil, Corn oil, Olive oil, Peanut oil, and Cottonseed oil were utilized, along with surfactants Tween 60 and Tween 80, and cosurfactants PEG 200 and Transcutol HP. Analytical validation parameters, including linearity and range, precision, limit of Detection (LOD), limit of Quantification (LOQ), ruggedness, robustness, and accuracy, were assessed according to the International Council for Harmonisation (ICH) guidelines. The solubility of NHCL in all of the aforementioned solvents was evaluated using the saturated solubility determination method. Results: Linearity analysis revealed a linear relationship, determined by an R2 value between concentration and absorbance. Intra-day precision demonstrates method reliability, with all Percent Relative Standard Deviation (%RSD) values ranging between 0.8426 and 1.9417%. LOD and LOQ values ranged between 1.1478 and 8.1632 µg/ml and 3.4783 and 24.7368 µg/ml, respectively. Ruggedness analysis exhibited good control over external experimental factors, with %RSD between 0.3433 and 1.9183%. Robustness assessment demonstrated consistent performance even with slight changes in environmental conditions, with %RSD between 0.5450 and 1.6443%. Accuracy study indicated % recovery values between 98.53 and 100.89%, suggesting minimal interference from excipients in the formulation. Conclusion: Caprylic Capric, as an oil/triglyceride, exhibited a solubility of 0.94 mg/ml. Tween-80, as a surfactant, showed a solubility of 23.58 mg/ml, and Transcutol HP, as a cosurfactant, demonstrated a solubility of 38.18 mg/ml for NHCL