ABSTRACT

Combination of Phenylephrine hydrochloride (PHEN) (10mg) and Cetrizine hydrochloride (CET) (5mg) have additive role in cough and anti allergic preparation, since both acts by attenuating the sign and symptoms of common cold and allergy. Here PHEN and CET have low dose in their combined dosage form i.e. 10 mg and less than 10 mg. According to Indian Pharmacopoeia standards, Content Uniformity can be carried out for such formulations. It was carried out by using Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method. The aim is to develop simple validated analytical method for simultaneous estimation of content uniformity of CET and PHEN. The RP- HPLC method was carried out by using mobile phase Methanol: Acetonitrile (94: 6, %v/v) with 1.0 min/ml flow rate and detection wavelength 220.0 nm. The regression analysis data for the calibration plot showed good linear relationship in the concentration range of 100?300 ?g/ml (R2 = 0.999) for CET and 200?600 ?g/ml (R2 = 0.999) for PHEN. The LODs were found to be 5.848 and 1.053 ?g/ml for CET and PHEN respectively. The % relative standard deviation <2.0 was obtained for the proposed method. Statistical analysis proves that the method is reproducible and selective for the simultaneous determination of CET and PHEN. Keywords: Cetrizine hydrochloride, Phenylephrine hydrochloride, Content Uniformity, RP- HPLC, Analytical method
Publication date: 01/04/2023

https://ijbpas.com/pdf/2023/April/MS_IJBPAS_2023_7039.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.4.7039