Abstract
In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min-1 using a Hibar® Lichrosorb® C18 column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL-1 and 0.1 to 0.8 ng mL-1 respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid.
Highlights
Pharmaceutical liquid preparations are vulnerable to microbial growth because of the nature of their ingredients
A few methods are available for determination of Cetirizine HCl (CTZ) and PCM as described earlier, but many of them are used only for certain definite objectives and none can be generalized for simultaneous determination of CTZ and PCM with mentioned preservatives in pharmaceutical products and serum
In order to solve the problems of the gradient elution, we developed and validated an isocratic high-performance liquid chromatographic (HPLC) method for the simultaneous determination of the four ingredients
Summary
Pharmaceutical liquid preparations are vulnerable to microbial growth because of the nature of their ingredients. Such preparations are protected by the addition of preservatives that prevent alteration and degradation of product formulation [1]. Antibacterial and antifungal properties of preservatives i.e. parabens, make them an integral part of liquid dosage formulation. (1)), are a group of the alkyl esters of p-hydroxybenzoic acid, have a low toxicity profile and a long history of use. Usage of MP is toxic at higher concentrations and has an estrogenic effect [3].
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