Abstract

Nilesh Takale^1,2, Neelakandan Kaliyaperumal², Gopalakrishnan Mannathusamy¹ and Rajarajan Govindasamy^1*

DOI : http://dx.doi.org/10.13005/ojc/370103

The quantitative analysis method for the quantitative analysis of the anti-histaminic drug Promethazine Hydrochloride (PMZ•HCl) is stated by a straightforward, smooth, reliable and reverse step of the ultra-performing liquid chromatographic method (RP-UPLC). Following ICH quidelinesQ2(R1), the RP-UPLC method has been developed and checked. The uniform solution of 3.4% KH2PO4 solution in water, 7.0 pH with dilute KOH, ACN, andMeOH in ratio of 40:40:20, used as a mobile phase. The flow of 0.6 mL/minusing photo diode array detector / UV detector by with wavelength of 254 nm and runtime 3 min. This gives linearty from 80-120 % with correlation coefficient of 0.99988. Repeatability and intermediate precision shows relative standard deviation (percent RSD) of 0.52, 0.24 and a overall RSD of 0.43. Robustness studies show no indicative changes in SST requirements, like asymmetry factor, theoretical plate & percentage relative standard deviation. These criteria's values are well within their acceptability limit. The degradation of promethazine under different stress conditions has been studied and shows that all known impurities and degradants are well separated from promethazine peak.This RP-UPLC is descriptive and accurate.

Assay; Promethazine hydrochloride; RP-UPLC; Validation

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