Tuesday , 5 March 2024

Method Development and Validation for Triprolidine and Phenylepherine in Bulk and Its Pharmaceutical Dosage Forms by Using RP-HPLC as per ICH Guidelines

Angara Ganesh1*, Gope Edward raju2, Vaddi Lakshmi Priya3, Doonaboyina Raghava4, Kavala Nageswara rao5
Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

A b s t r a c t
High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Triprolidine and Phenylephrine was done by RP-HPLC. The Phosphate buffer was pH4.5 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of PH 4.5(20:80 v/v). Kromosil C18 column (250mm x 4.6mm) 5µg or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 254 nm. The solutions were chromatographed at a constant flow rate of 1ml min-1. The linearity range of Triprolidine and Phenylephrine were found to be from 100-500 mg/ml of Triprolidine and 1-5mg/ml of Phenylephrine. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. Triprolidine % RSD 0.2 and Phenylephrine % RSD 0.6.Intermediate precision for Triprolidine %RSD 0.2 and Phenylephrine%RSD0.1The percentage recovery varies from 98-102% of Triprolidine and Phenylephrine. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements .it inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
Keywords: Kromosil C18, Triprolidine and Phenylephrine, RP-HPLC

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