Tushar A. Deshmukh

In the current investigation we formulated and evaluates matrix tablet using modified gum of Pistacia lantiscus gum (PLMG) as natural matrix forming agent used in various successively increasing concentration. The pre-compression study of the powder blends of drug, PLMG and other excipients were done by calculating bulk density, tapped density, angle of repose and carr’s index (% compressibility) and hausner’s ratio. The tablets using PLMG as matrix forming agent were prepared by direct compression method and prepared tablets were evaluated for thickness, hardness, weight uniformity, friability and content uniformity and were found according to the official guidelines by pharmacopoeia. The swelling behavior of prepared matrix tablets was studied using for 12 hours at 37 ±0.2 0C, it was fond that the drug to modified gum ratio of 1:2 was found to be optimum swelling with the sustained release of model drug up to 97.12 in matrix tablet formulation. The results revealed, that modified fraction of Pistacia lantiscus gum can be used as a drug release modifier to delay as the rate of drug release of which depended on the amount of gum composition, as the concentration of gum was increased there was sustain the drug release.

A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of Dapoxetine hydrochloride in bulk and in formulation. Chromatographic separation was performed on aluminum plate precoated with Silica Gel 60 F254 using Ethyl Acetate: Methanol (9:1 v/v) as the mobile phase with saturation time 20 min, followed by densitometric scanning at 239 nm. This system was found to give compact spot for Dapoxetine hydrochloride (Rf value 0.78 ± 0.005) and specificity in accordance with international conference on harmonization (ICH) prescribed stress conditions. The calibration curve was found to be linear between 100-700 ng/band. The proposed method was found to be accurate, precise, reproducible, specific and sensitive and applicable for the determination of Dapoxetine in bulk and in formulation. The drug was subjected to stress condition of hydrolysis (acid, base and neutral), oxidation, photolysis and thermal degradation.