Method development and validation of stability indicating rp hplc method for estimation of antihistaminic drugs in combination with pseudoephedrine in pharmaceutical formulation

Abstract

quotVarious Antihistaminic drugs are available in market in combined dosage form. Antihistaminic drugs are the first class choice for the cough suppression and also in the management for the relief of symptoms of seasonal allergic rhinitis, perennial (non-seasonal) allergic rhinitis in both adult and child. Aim: newlineMany official methods and reported methods are available for determination of Antihistaminic drugs along with pseudoephedrine but most of the methods require complex operating conditions and are too much time consuming. Therefore, a stability indicating HPLC methods for estimation of Antihistaminic drugs in combination with Pseudoephedrine is developed and validate. newlineMaterials and Methods: newlineA simple, accurate, precise, rapid and economical stability indicating HPLC methods for estimation of Antihistaminic drugs in combination with Pseudoephedrine and also to validate the newly developed methods according to ICHQ2R1 guidelines to ensure their linearity, accuracy, precision, repeatability, reproducibility, system suitability and other analytical method validation parameters as per ICH guidelines. newlineResults and Discussion: newlineThese stability indicating HPLC methods of Pseudoephedrine Sulphate in combination with Loratadine Hydrochloride, in combination with Fexofenadine Hydrochloride, in combination with Desloratadine Hydrochloride and in combination with Cetirizine Hydrochloride are linear with R2 value greater than 0.999. These methods are accurate with recovery between 98 % and 102%. All methods are rugged and precise with C.V value below 1.0 %. All methods show different degradation in different condition. newlineConclusions: newlineThese methods also applied to marketed formulation of combined dosage form. So, these methods are useful in industry and it is beneficial as stability indicating method with different stress condition developed and validated as per ICH Guidelines.quot