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The present study describes a new accurate and precise stability indicating reverse phase HPLC method for quantitative computation of pantoprazole sodium and Aspirin from physical simulated mixture. The proposed chromatographic method employs Hypersil ODS C18 column (250 x 4.6 mm, 5μ) as the stationary phase and combination of methyl alcohol and water in ratio of 70: 30 v/v as the elution medium. Overall separation was carried out at 0.8 ml/minute flow rate and elution was monitored at 254 nm. The proposed system gave well resolved peak of Aspirin and Pantoprazole sodium with elution time of 2.32 and 5.85 minute respectively. Same system was effective in separation of active components and degradation products when the components were subjected to forced degradation as per regulatory guidelines (ICHQ1). Finally, the optimized method was successfully validated as per ICH Q2R1 guidelines and applied for quantitative analysis of both active components in synthetic mixture.

Current research paper describes highly specific and reproducible 1 order derivative spectroscopic method for quantitative analysis of Sitagliptin which is a DPP4 inhibitors and Dapagliflozin which is SGLT2 inhibitors from its synthetic mixture. Both drugs are from Anti Diabetics class. Present analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methyl alcohol as solvent. Quantification of Sitagliptin was carried out at zero cross over point of Dapagliflozin that is 275 nm and for Dapagliflozin, it was achieved at 232 nm which is zero cross over point of Sitagliptin. Method shows linear response in the range of 25-125 µg/mL of Sitagliptin and 2.5-12.5 µg/mL of Dapagliflozin. Method was found to be accurate with recovery between 99.3 – 100.1 % for Sitagliptin and 98.2 – 100.7 % for Dapagliflozin. The developed method was validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of synthetic mixture of Sitagliptin and Dapagliflozin.

Nano Structured Lipid Carriers (NLCs) are potential alternative of the tradition colloidal drug carrier. The main benefit is related to the well-known concept that lipids used in nanoparticle formulation promote drug oral absorption because they go through the same physiological mechanism as food lipid digestion. The objective of the present work is to use potential carrier NLCs for the oral delivery of poorly soluble drug Febuxostat (FEB). FEB-NLCs were formulated by High Speed Homogenization with Ultra sonication method using Capmul GMS 50 K as solid lipid and Transcutol HP as a liquid lipid. The 32 full factorial design utilized to study the effect of influence of solid lipid to liquid lipid ratio and concentration of surfactant, on the particle size and entrapment efficiency. Mean particle size and entrapment efficiency were found for all prepared formulation in the range of 196.66±2.08 nm to 368.33±2.51 nm and 74.80±0.52 % to 86.47±0.749 % respectively. Zeta potential was -15.2mv which is negative enough to give good stability. TEM study shows good spherical morphology of particle with diameter less than 200nm. In-vitro and Ex-Vivo study revel that NLCs gives biphasic release of the drug; first initial burst release and then sustained release up to 24 hour. The formulated NLCs dispersion was successfully converted in to the free flowing powder using trehalose as a cryoprotectant. In conclusion, FEB-NLCs potential carrier for the oral delivery and controlled release of drug which may reduce dosing frequency and improve patient compliance.

The aim is to develop and evaluate rizatriptan benzoate (RB) loaded nanostructured lipid carriers (NLCs) that might improve oral bioavailability. NLC was prepared using High-Speed Homogenization (HSH) coupled with the ultrasonication method. Process parameters were selected on basis of the trial-and-error method which is time for homogenization, speed of homogenization, and time for sonication. Using a Design expert, 32 Full Factorial design was prepared using solid lipid to liquid lipid ratio and concentration of surfactant as independent variables. RB-NLC was evaluated on basis of particle size, %Entrapment Efficiency (EE), Zeta potential, Transmission electron microscopy (TEM), In-Vitro permeation study, and Ex-vivo permeation study. Confocal Laser Scanning Microscopy was performed to study the uptake of RB-NLC through M-Cells, and Peyer's Patches. RB-NLC dispersion was converted into free-flowing lyophilized powder using cryoprotectant which is trehalose and in vitro permeation study was performed. Among all the batches of RB-NLC, the Optimized batch was evaluated. The optimized formulation showed a particle size of 412.8 ± 1.15nm with 0.261 PDI and − 36.6mV zeta potential. It showed 84.26 ± 1.03% EE. TEM image showed a spherical shape and smooth surface area. In-Vitro and Ex-vivo studies showed 97.21 ± 0.36%CDR up to 22 hours & 61.02 ± 1.25%CDR up to 6 hours. Lyophilized powder showed 96.37 ± 0.36%CDR up to 22 hours. Based on the data we can conclude that RB-NLC increases the permeation and it may increase its Bioavailability (BA). Lyophilized powder of RB-NLC showed a sustained release pattern and it may reduce the dosing frequency of the drug.

Objective: The preliminary goal was to develop and validate 1st order derivative spectroscopic method for quantitative analysis of Pamabrom (PAMA) which is a xanthine diuretic and ibuprofen (IBU) which is a non-steroidal anti-inflammatory agent from its synthetic mixture. Methods: Analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methanol as solvent. Quantification of PAMA was carried out at zero cross over point of IBU that is 291 nm and for IBU, it was achieved at 278 nm which is zero cross over point of PAMA. Method was validated according to ICH Q2 R1 guidelines. Results: Method showed a linear response in the range of 2-12 µg/ml of PAMA and 20-120 µg/ml of IBU. Method was found to be accurate with recovery between 99.7–100.9 % for PAMA and 100.3–100.7 % for IBU. The method was found to be accurate and precise for quantitative analysis of PAMA and IBU. Conclusion: The developed method was successfully validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of a synthetic mixture of PAMA and IBU.