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Background: A novel stability indicating analytical method was developed and validated by High Performance Thin Layer Chromatography (HPTLC) using Design of experiment approach. The proposed method is useful for quantification of Metformin hydrochloride and Empagliflozin in bulk and its dosage forms simultaneously. Design of experiment approach was applied for optimization of chromatographic conditions. Materials and Methods: For optimization process independent variables were used as Isopropyl alcohol proportion in mobile phase, saturation time of chamber and distance travelled by mobile phase. Experiments were carried out on silica gel pre-coated plate using mobile phase as 2 % Ammonium acetate: Isopropyl alcohol: Triethylamine (4:6:0.1 v/v/v). Direct evaluation of chromatograms were done by TLC scanner with reflectance/absorbance mode set at 242 nm. Method was validated as per ICH Q2 (R1) requirements. Results: Correlation coefficients for calibration curves were found to be 0.985 and 0.988, the calibration curve is in concentration range of 5000-30000 ng band-1 and 125-750 ng band-1 for Metformin hydrochloride and Empagliflozin respectively. The method showed % recovery between 99.05 to 102.54 % for Metformin hydrochloride and 99.20 to 101.50 % for Empagliflozin. The method has a prospective to determine Metformin hydrochloride and Empagliflozin simultaneously. The Metformin hydrochloride and Empagliflozin were subjected to forced degradation studies like hydrolysis, oxidation, thermolysis and photodegradation. Conclusion: Proposed method has capacity to separate the Metformin hydrochloride and Empagliflozin in its degradation products. Hence one can apply this method effectively for routine analysis and during stability study as per regulatory requirements.

Nanosponges are the recent advances in nanotechnology. Nanosponge delivery system was originally developed for topical drug delivery. Nowadays it can also be used for oral delivery of drugs using water soluble and bio erodible polymers. Nanosponges are porous structures with a size of about a virus (average diameter below 1µm). Due to small size and porous nature; nanosponges can bind to poorly soluble drugs and improves their bioavailability. These nanosponges can circulate within body and interact with specific target site. At target site start releasing the drug in a controlled manner. Various techniques are reported for the preparation of Nanosponges as melt method, solvent diffusion method, solvent method, ultrasound assisted method and sonication etc. Nanosponges are the target specific drug delivery which has lesser side effects. Major advantage of nanosponges as it improves solubility of poorly soluble drug and exhibits higher drug loading as compared to other nanocarriers. This review gives the highlights about the formulation methods, excipients used, evaluation of nanosponges and its benefits to overcome the undesirable properties of drug into desirable.

The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the terms atorvastatin, Fluvastatin, pitavastatin, ruvastatin, simvastatin, and pravastatin are used. assist the selection of formulations and packaging as well as proper storage conditions.

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