Development and validation of a reversed-phase ultra-performance liquid chromatographic method for assay of lacidipine and related substances.
A simple isocratic, RP-ultra-performance LC method was developed and validated for the determination of lacidipine, three process impurities formed during synthesis, and three degradation products present in drug substance and the drug product. An efficient chromatographic separation was achieved on an Acquity BEH C18 column using pH 4.5 ammonium acetate-acetic acid buffer-methanol (70 + 30, v/v) mobile phase. The monitoring wavelength was 240 nm, and the flow rate 0.25 mL/min. Forced degradation studies using acid, alkali, peroxide, water, heat, and light were conducted, and all impurities were separated. The method was validated successfully for specificity, precision, linearity, accuracy, LOD, LOQ, and robustness, according to International Conference on Harmonization guidelines. The linearity of the calibration curve for lacidipine and each impurity was found to be very good (r2 > 0.999). This method is shown to be suitable for analysis of lacidipine to evaluate the quality of drug substance and a drug product.
National Collage, Department of Chemistry, Trichirapalli-620001, Tamilnadu, India. arivozhimohan@hotmail.com
Arivozhi
A
Mohan
Hitesh B
HB
Patel
Dhandayutham
D
Saravanan
D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004095:Dihydropyridines / Q000032:analysis*; D004355:Drug Stability; D057230:Limit of Detection; D004364:Pharmaceutical Preparations / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D004095:Dihydropyridines; D004364:Pharmaceutical Preparations; C060285:lacidipine