Formulation Developement of Azelnidipine and Telmisartan in FDC and Simultaneous Estimation of its Active Ingredients Impurities by Using Stability Indicating Validated Analytical RP HPLC Method

Abstract

Result obtained from Preformulation studies, Drug-Excipient Compatibility study and newlineFormulation studies, it was concluded that B4 trial formulation batch meets all newlinespecified criteria; hence it was used for scale up tablet formulation of Azelnidipine 8 newlinemg and Telmisartan 40 mg. newlineThe Analytical method was developed and validated using RP-HPLC, in gradient newlinemode for quantitative estimation of % Assay and % Release of Azelnidipine and newlineTelmisartan tablets 8/40 mg. Stability Indicating Assay method was able to separate newlinethe drugs from their degradation products and may be used for analysis of stability newlinesamples of Azelnidipine and Telmisartan. The results obtained from Assay and newlineDissolution method validation demonstrated that, the HPLC method was specific, newlineaccurate, precise, linear and rugged. The method was found robust at variation in the newlinecolumn temperature, variation in mobile phase ratio, wavelength and variation in flow newlinerate. newlineImpurity Profiling analytical method was developed and validated using RP-HPLC newlinefor Azelnidipine 8 mg and Telmisartan 40 mg tablets as per ICHQ2(R1) Guideline. newlineWhen evaluated on various parameters like system suitability, specificity, precision, newlineaccuracy, linearity, force degradation study, LOD, LOQ, solution stability, it can be newlineconcluded that the method was efficient in separating drugs from their Impurities and newlinecan be utilized for analysis the samples of Azelnidipine and Telmisartan. Solution newlinestability established and found standard solution was stable up to 2 days at room newlinetemperature (RT). newlineFurther, Long Term and accelerated stability study samples charged at Temp. 30 ± newline2ºC/75% ± 5 RH and Temp. 40±2ºC/ 75%±5% RH respectively up to 06 Months. newlineFrom stability study, it was concluded that, the proposed formulation was stable up to newline06 months, hence shelf life of formulated tablets will be 12 months as per ICH QIA newline(R2) guidelines and New Drugs and Clinical Trials Rules, 2019. newlineComparative evaluation studies were conducted with approved brands which was newlineavailable in market, it was concluded that, the formula