Stability Assessment through HPTLC for Concurrent Assessment of Azelnidipine and Telmisartan in Mass and Integrated Tablet Drug Formulation

This study aims to estimate the stability assessment through HPTLC for the concurrent assessment of (±)3-(1-diphenylmethylazetidin-3-yl)5-isopropyl-2-amino-1,4-dihydro-6-methyl-4-(3-nitrophenyl)-3,5-pyridine dicarboxylate (Azelnidipine) and 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl] phenyl]benzoic acid (Telmisartan) in combined tablet formulation, a new HPTLC approach devised and validated that is simple, quick, precise, selective, and accurate stability suggesting. The adsorbent phase used is previously coated with a silica pack on TLC aluminum plates with 60F-254 using Chloroform: Ethyl acetate (5:5 v/v) of a total of 10 ml as the mobile phase. Both Azelnidipine (Rf 0.70) and Telmisartan (Rf 0.17), at 254 nm, densitometric scanning was performed in the reflectance absorptivity mode. In the linearity range of 1-6 μg/ml for Azelnidipine and 5-30 μg/ml for Telmisartan, the calibration graph demonstrated satisfactory linearity with r2 = 0.9967 and 0.9966, respectively. Azelnidipine and Telmisartan percentage assays were discovered to be 98.87 and 100.17. The percent RSD for intraday AZL and TLM experiments was 0.0184 and 0.0068. The percent RSD for AZL and TLM interday trials was discovered as 0.0126 and 0.0068. The LOD for AZL and TLM was discovered as 910 ng/mark and 4570 ng/mark. AZL and TLM were discovered to have LOQs of 2763 ng/mark and 13850 ng/mark, respectively. According to the ICH guidelines, drugs were exposed to acidic, basic, oxidative, photo, and heat-activated degradation. The medication degrades in acidic, basic, oxidative and heat environments but not in light or neutral environments (water). This procedure can be used to efficiently isolate the drug substance from its degradation products and this is used to indicate strength and stability.. KEYWORDS :Azelnidipine, Telmisartan, HPTLC, UV-visible spectroscopy, Validation, Stability studies.