Simultaneous HPLC determination of nitrendipine and impurities of the process of synthesis.
A method has been developed for separation of nitrendipine and its impurities of reaction partners and side reaction products by high-performance liquid chromatographic method on a RP-18 column and detection at 238 nm. The mobile phase composition that provided an acceptable nitrendipine resolution, in large excess and possible impurities, in a short elution time, is methanol:water (70:30) and pH 3. Linearity (r> or =0.999), reproducibility (RSD=0.8--1.4%), determination limit (0.5--2%) and recovery (99.8--102.3) were validated and found to be satisfactory. This method enables monitoring of the process of synthesis, as well as the choice of the synthetic design.
A.D. Zdravlje, Pharmaceutical and Chemical Industry, 16000 Leskovac, Serbia, Yugoslavia.
V
V
Marinkovic
D
D
Agbaba
S
S
Vladimirov
S
S
Stankovic
D002121:Calcium Channel Blockers / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D009568:Nitrendipine / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D002121:Calcium Channel Blockers; D009568:Nitrendipine