Abstract

Nilesh Takale¹, Neelakandan Kaliyaperumal², Gopal Krishnan¹, Mannathusamy² and Raja Rajan Govindasamy²

DOI : http://dx.doi.org/10.13005/ojc/360513

A smooth, specific, precise, and accurate, high-performance reverse phase (RP-HPLC) method for determining related antihistamine substances Promethazine Hydrochloride (PMZ∙HCI) has been recorded. The RP-HPLC system is developed and tested in compliance with recommendations Q2(R1) of the International Council for Harmonization (ICH). Column 5 and reverse step with linear gradient elution is accomplished in Symmetry Shield RP8 (4.6 mm x 150 mm). Mobile phase A is 3.4% in the 7.0 pH water, modified to dilute potassium hydroxide solution. In contrast, the 60:40 mixture of acetonitrile and methanol combination as mobile phase B. The handled phase with a continuous flow rate of 1.0 ml min−1 is provided by choosing the wavelength 254 nm using a PDA / UV detector. The temperature of the column oven and sampler is 25°C and 4°C, respectively. The injection amount chosen is 10.0 μL. The method is linear in the quantitation limit range (LOQ) to 150 percent concerning the specification impurity concentration limit. Both impurities and PMZ have a correlation coefficient of greater than 0.999. The LOQ for all known impurities and PMZs has a specification limit of between 10 to 30%. The relative response factor for all four known impurities is calculated. The unexplained peaks are very different; the effects obtained are similar to the original values. There are no significant improvements to the device suitability parameters, such as tailing factor, theoretical sheets, and RSD rate in Robustness Studies. The forced degradation analysis of PMZ∙HCI was performed. This RP-HPLC is descriptive, accurate, and precise. This further defines the parameters of linearity, consistency, and robustness used for regular quality control analysis.

Anti-Histaminic; PMZ•HCI; Quantitative Analysis; RP-UPLC; Stability Indicating

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