Mehta Saumil, Singh Sukhdev, Chikhalia Kishor
Torrent Research Centre, Bhat, Gandhinagar, Gujarat, India.
Department of chemistry, school of sciences, Gujarat University, Ahmedabad, Gujarat, India.
Sci Pharm. 2014 Jan 16;82(2):327-40. doi: 10.3797/scipharm.1310-10. Print 2014 Apr-Jun.
A robust, sensitive, and stability-indicating rapid resolution liquid chromatography method for the simultaneous determination of process impurities and degradation products of lercanidipine hydrochloride in pharmaceutical dosage form was developed and validated. The chromatographic separation was performed on the Zorbax SB C18 [(50 × 4.6) mm] 1.8 μm column, using gradient elution of a potassium dihydrogen phosphate buffer (pH 3.5, 0.01 M) and acetonitrile. The flow rate was 1.0 ml/min and UV detection was performed at 220 nm. The method was further evaluated for its stability-indicating capability by hydrolytic, oxidative, thermal, thermal with moisture, and photolytic degradation studies. All acceptance criteria of the International Conference on Harmonization guidelines for validation were covered in the method validation. This method can be used for purity control during manufacture and real time stability studies. A shorter run time of 10 minutes and good solution stability for at least 48 hours allowed the quantification of more than 50 samples per day with comparatively lower costs than existing methods.
建立并验证了一种用于同时测定盐酸乐卡地平药物剂型中工艺杂质和降解产物的稳健、灵敏且具有稳定性指示功能的快速液相色谱方法。色谱分离在Zorbax SB C18 [(50×4.6) mm] 1.8μm柱上进行，采用磷酸二氢钾缓冲液（pH 3.5，0.01 M）和乙腈的梯度洗脱。流速为1.0 ml/min，在220 nm处进行紫外检测。通过水解、氧化、热、湿热和光解降解研究进一步评估该方法的稳定性指示能力。方法验证涵盖了国际协调会议验证指南的所有接受标准。该方法可用于生产过程中的纯度控制和实时稳定性研究。10分钟的较短运行时间以及至少48小时的良好溶液稳定性使得每天能够定量分析50多个样品，且成本相对现有方法更低。
