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An efficient column friendly, buffer free, highly sensitive, cost effective RP-HPLC method was developed by considering the criticality of different method parameters on analytical attributes like tailing factor, resolution and retention time in preliminary risk analysis and screening designs. The Pareto analysis of screening design highlighted the need for optimization of resolution and its influencers (capacity factor and theoretical plates) for both the drugs to imbibe quality in the method. The suggested method of optimization design was developed using ZODIAC C18 ODS (250 mm × 4.6 mm, 5 μm) column in isocratic mode using mobile phase acetonitrile : methanol : water in the ratio of 60:10:30 at a flow rate of 0.8 mL/min and UV detection wavelength of 262 nm. The retention times of drugs were found to be 3.488 minutes for sofosbuvir, 5.387 minutes for velpatasvir. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.997 for sofosbuvir, r2=0.988 for velpatasvir, in the working concentration range of 1000-5000 ng/mL, 250-1250 ng/mL respectively. The AQbD devised method was applied for quantification of drugs in plasma and validated as suggested in ICH M10 guidelines.

Aim: Self nano-emulsifying drug delivery system (SNEDDS) of candesartan cilexetil was explored to enhance its oral bioavailability. SNEDDS has tremendous potential in enhancing oral bioavailability of poorly aqueous soluble therapeutic agents. SNEDDS are pre-concentrate mixture of oil, surfactant and co-surfactant produces nanoemulsion after oral administration due to mild agitation produced by gastro motility within the size range of 20-200nm. Methodology: The formulations were developed by selecting capmul MCM®, triacetin® and caprylic acid® under the oil phase based on solubility of drug; cremophore RH40®, brij35® under surfactants category and transcutol P under co-surfactant on basis of their emulsification property. Optimum concentrations were choosen from the Terinary phase diagrams and evaluated for their properties. Results: From the results of ternary diagrams 16 formulations were selected (A1, A2, A3, A4, B1, B2, C1, C2, C3, C4, D1, D2, E1, E2, F1, F2) and subjected to characterization studies. Best formulations were subjected to particle size analysis and in vitro release studies. Among selected formulations, A1 and C1 have shown high in vitro drug release profiles with less selfemulsification time having grade A dispersibility without any precipitation and phase separation. Discussion: Concentration of surfactant helps in reducing the size of the particle when compared to the co-surfactant concentration. Enhanced dissolution of candesartan cilexitil may be attributed to the spontaneous formation of nanoemulsion in vitro with a decreased particle size that leads to the increased surface area leaving the drug candesartan as finely dispersed particles in dissolution media. Conclusion: Formulation C1 consists of triacetin oil 30% w/w, cremophore RH 40 6%w/w and transcutol P 64%w/w showed best emulsification characteristics like 99% percent transmittance, with increased dissolution profile (98%) than pure drug (45%) with nano range goblet size (165.9nm).

The major objective of this study was to investigate the effect of biodegradable polymer type and surfactant concentration on various characteristics viz. particle size, entrapment efficiency and drug release rate constant of aqueous core nanocapsules (ACNs) containing tenofovirdisoproxil fumarate. In this study, the nanocapsules were prepared by modified multiple emulsion technique with biodegradable polymers viz. poly(lactide-co-glycolide) of two different grades (PLGA RG502H and PLGA RG503H) and poly lactic acid (PLA R203H); and the surfactant employed was span 80. The experiments were designed under response surface methodology by employing the Design Expert software. Entrapment efficiency, particle size and drug release rate constant were taken as response variables. The prepared nanocapsules were subjected to characterization studies and the obtained results were statistically analyzed by Analysis of Variance (ANOVA) for response surface 2-Factorial Interaction model. ANOVA studies showed that the influence of both factors on all the response variables were significant at p

A rapid, accurate and precise LC-MS method is described for the quantitative determination of pramipexole in human plasma matrix using ropinirole as internal standard. Pramipexole and ropinirole were extracted from plasma by liquid-liquid extraction technique. The method was validated over the concentration range of 100-2514 pg/mL. The method was found to have acceptable accuracy, precision, linearity and selectivity. The mean extraction recovery from spiked plasma samples was in the range of 79.415-87.00 %. The intra-day accuracy of the assay ranged from 98.924 to 112.236 % and intra-day precision ranged from 3.489 to 6.756 %. Inter-day accuracy and precision results for quality control samples ranged between 100.340 and 107.443% of nominal and precision is observed to be 3.970-5.714 %. The pramipexole was found to be stable after several stability studies. The proposed method yielded a quick, simple and reliable protocol for estimating pramipexole concentrations in human plasma.

In the present study, two sensitive, precise and accurate spectrophotometric methods have been developed for the determination of milnacipran in bulk and capsule formulation. The first method is based on the reaction of milnacipran with ninhydrin in N,N'-dimethylformamide medium at 80°C temperature to form a colored Ruhemann's purple, which exhibits absorption maximum at 575nm. The second method is based on extraction of milnacipran into chloroform as ion-pair with bromothymol blue. The yellow colored ion-pair complex exhibits absorption maximum at 410nm. Beer’s law is obeyed in the concentration ranges 2.5-37.5μg/mL and 2-12μg/mL of milnacipran for methods I and II, respectively. The effect of experimental variables were investigated and optimized. The validation parameters like linearity, sensitivity, accuracy, precision and robustness were checked by following the ICH guidelines. The proposed methods were applied for the analysis of milnacipran in capsule formulation with good results.

The present study has been conducted to evaluate the antiasthmatic potential from the inflorescence extracts of Gomphrena serrata. to validate its traditional use. The antiasthmatic activity of hydroalcoholic and acetone extracts was studied by two models histamine and acetyl choline induced bronchospasm in guinea pigs and histamine and acetyl choline induced contraction on isolated guinea pig ileum. The preconvulsive time at a dose of 400mg/Kg in guinea pigs and inhibition of contractions on guinea pig ileum at a concentration of 0.5mg were investigated and compared with the control groups. Phytochemical studies revealed the presence of flavonoids, phenolics, steroids, triterpenoids. The extracts have significantly reduced the bronchospasm induced by histamine and acetylcholine, as well as the contractions of ileum. Therefore the present study concludes that the hydroalcoholic and acetone extracts of Gomphrena serrata exhibited antiasthmatic activity which may be due to phytochemical substances probably causing suppression of antibody production or inhibition of antigen induced histamine and acetylcholine. QR code Key words: Gomphrena serrata, asthma, bronchospasm, histamine, acetylcholine

Context: Liver disorders have become a common problem worldwide. The drugs available currently for the treatment are few with serious side effects. Since phytochemicals have proven to be potential therapeutic agents, an attempt has been made to screen novel hepatoprotective agents from the leaves of the medicinally ignored plant Talinum portulacifolium. Aims: To evaluate the phytoconstituents of Talinum portulacifolium responsible for hepatoprotective activity in carbon tetrachloride-induced hepatotoxicity models both in vitro and in vivo. Methods: The hepatic damage was assessed in vitro by serum marker enzymes alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase followed by in vivo histopathological examination. Results: The results of the study indicate that the plant hydroalcoholic and acetone extracts at 500 mg/kg and compound 2-piperidone at 0.5 mg/kg exhibited equipotent results in the reduction of biochemical marker enzymes (p