Based on the current regulatory requirements for analytical method development, a RP-HPLC method for quality control of dolutegravir in dosage form has been optimized using analytical quality by design (AQbD) approach. Experimental observations were analysed by full factorial experimental design in Sigmatech software with two variables (flow rate and % organic mobile phase) whilst the number of theoretical plates was considered as response. The analytical method conditions were optimized as mobile phase (40:60 % V/V) consisting of acetonitrile and ammonium formate buffer, pH 3.0 pumped at a flow rate of 0.6 mL/min in an isocratic mode on SPOLAR C18 Column (250 x 4.6mm, 5μm) with run time of 15 min. The plot between peak area vs. concentration was rectilinear in the range of 5-30 μg/mL with detection and quantification limit values at 0.01 and 0.3μg/mL, respectively at retention time of 13 min. The predicted data from contour diagram for theoretical plates was verified virtually and it was contented with concrete experimental data. The method was validated as per ICH guidelines. The proposed method was pertinent for assay of marketed dosage form (Tivicay) and further extended to quantify the drug in prevalence of degradation products. Degradation pathways of dolutegravir were postulated and characterized by IR and mass spectral data.

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The aim of the present study is to develop and evaluate the immediate release tablet of tapentadol by direct compression method. The superdisintegrant explotab, solutab and polyplasdoneXL were used for immediate release of drug from tablet. The prepared tablets were evaluated for all pre-compression parameters and post-compression parameters. The drug-excipients interaction was investigated by FTIR. All formulation showed compliances with Pharmacopoeial standards. The study reveals that formulations prepared by direct compression F2 exhibits highest dissolution using explotab showed faster drug release 95.48 % over the period of 45 min while disintegration time of the tablet was showed 12 sec in comparison to other formulations of tapentadol.

Quality by design refers to the achievement of certain predictable quality with desired and predetermined specifications. The objective of this study was to demonstrate an integrated multivariate approach to quantify the constituent concentrations of alogliptin and metformin in combination by simultaneous assessment method using Sigma Tech software with three variables (flow rate, pH of the buffer and % of organic phase) at two levels (first order) and to observe the effectiveness of those variables on response as theoretical plates to optimise the critical method parameters. The method conditions were optimized using a SPOLAR C18 (250 mm × 4.6 mm id, 5 µm particle size) column in an isocratic mode with potassium dihydrogen phosphate buffer, pH 3 and acetonitrile (80:20 % V/V) as mobile phase pumped at a flow rate of 0.5 mL/min and UV detection at 235 nm. The analytical method conditions were verified for robustness and validated as per standard guidelines. The linear regression analysis data for calibration plots showed good linear relationship with r2 =0.999 for both the drugs in the working concentration range of 5-25 µg/mL for alogliptin and 50-250 µg/mL for metformin, with retention times 11.68 and 4.98 min, respectively. The proposed method was applied for quantification of the studied drugs in tablets, spiked human plasma and the results revealed percentage recovery of 99-100 % for both alogliptin and metformin. Moreover, the method was also utilized to study the in vitro dissolution profiles of marketed tablets as per FDA dissolution data base.