A very simple, accurate, precise, robust, rugged and stability indicating method with gradient elution was developed for simultaneous estimation of Empagliflozin and Linagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Empagliflozin and Linagliptin by using C18 (Equisil BDS) column (4.6 × 250 mm) 5μ, flow rate was 0.7 ml/min, mobile phase ratio was (40:60 v/v) methanol: water, detection wavelength was 224 nm and 294 nm. The instrument used was SHIMADZU-HPLC system, Pump-HPD 20A, Detector-UV detector, Software-UV Probe. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The Linearity study of Empagliflozin and Linagliptin was found in concentration range of 20 μg-40 μg, 60 μg, 80 μg, 100 μg and 10 μg, 20 μg, 30 μg, 40 μg, 50 μg correlation coefficient (r2) was found to be 0.988 and 0.991, % recovery was found to be 99.1% and 99.6.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.