ANALYTICAL ESTIMATION AND VALIDATION OF GENOTOXIC IMPURITY IN PROMETHAZINE HYDROCHLORIDE OF INDIAN MARKETED FORMULATIONS USING GC-MS
Kandula Kiriti Kalyan Kumar*, Dr. NDVR Saradhi and Dr. M. Venkata Reddy
ABSTRACT
The main aim of the work to develop a simple, sensitive and rapid method for the estimation of Dimethyl Amino Isopropyl Chloride in Promethazine API and formulations by GC MS method. The method is developed by using GC column of 30m*0.32 mm*1.80 um and Helium as carrier gas; The MS conditions are fixed with ESI at 2200C with interference temperature of 2500C and ions are trapped by ion collector and detected by photomultiplier tube detector using single ion monitoring mode (SIM) at m/e of 121 to determine Dimethyl amino isopropyl chloride in standard and samples. The peak obtained at 6.773 min for Dimethyl amino isopropyl chloride and 7.812 min for Promethazine. The analytical method is validated as per USFDA impurity guidelines for its System Suitability, Accuracy, Precision, Intermediate precision and Method precision whose %CV were found to be 9.21, 85 – 89%, 5.68, 5.68, 5.89 respectively for Dimethyl Amino Isopropyl chloride and Limit of Detection and Limit of Quantification were be at 0.075 and 0.025 ppm respectively and the range between 0 to 3.8 ppm. The method is applicable for the analytical estimation of Dimethyl amino isopropyl chloride in academic research, BA/BE studies in Promethazine API, marketed formulations and Biological samples.
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