JPTRM Vol. 1 No. 2 (November 2013)
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Item Development and Validation of Static HS-GC Method for the Determination and Quantification of Residual Solvents of Bromhexine Hydrochloride (BHX)(Chitkara University Publications, 2013-11) Prafull Mathur; Suvigya Mathur; Anand Kumar Mishra; Tanaji KunjirThe determination of residual solvents in drug substances is the mandatory requirement by various health authorities in the world. There are no analytical methods available in the literature that can simultaneously separate and quantitate residual solvents in bromhexine hydrochloride (BHX) active pharmaceutical ingredient (API). This paper describes the development and validation of a simple, efficient, accurate, and robust static headspace gas chromatography method for the determination of residual solvents, namely methanol, ethanol, ethyl acetate, monochlorobenzene, and benzene, in BHXAPI. This new method has been demonstrated to be accurate, linear, precise, reproducible, specific, and robust for its intended purpose. The method gives very good sensitivities viz. detection limits for benzene is 0.4 ppm, ethyl acetate 2 ppm and for others solvents 5 ppm and precision (below 9.0 % RSD) for all solvents. The results of this evaluation strongly indicate that this method can be readily used to determine residual solvents in BHX.Item Analytical Method Development and Validation for Assay of Rufinamide Drug(Chitkara University Publications, 2013-11) Jitender Singh; Sonia Sangwan; Parul Grover; Lovekesh Mehta; Deepika Kiran; Anju GoyalA simple, rapid, sensitive, cost effective, and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the stability testing of rufinamide. The proposed RP-HPLC method was developed on phenome-nex LunaR C-18 5μm,250 mm × 4.6 mm id. Column (at ambient temperature) and a mobile phase consisting of phosphate buffer: acetonitrile (60:40) was delivered at a flow rate of 1.0ml/ min. The analyte was detected by using a UV detector at the wavelength of 293 nm. The method was found to be linear over the concentration range of 50- 150 μgml-1 (r2=0.999). 30. The retention time of rufinamide was 4.717 min.Item Association of ABO Blood Groups with Cardiovascular Diseases in Adult Indian Population(Chitkara University Publications, 2013-11) Pooja Sahita; Indermeet Singh Anand; Manisha ShahThis study was designed to investigate whether there was an association between ABO blood groups and major cardiovascular diseases (ischemic heart diseases) in adult Indian population. The present retrospective study analyzed ABO blood groups among 1527 patients with documented IHD, who were treated at CIMS Hospital in Ahmedabad city from January to December, 2011 comparing with a control group of 860 subjects. Data were analyzed with GraphPad Prism 6.0 and by using chi square test. A p-value less than 0.05 were considered as +statistically significant. No significant difference in distribution of ABO blood groups was seen in patients with IHD (A, 21.95%; B, 35.41%; AB, 8.61%; O, 34.01%) and also after adjustment for common cardiovascular risk factors such as age, gender, addiction history, obesity, hypertension, diabetes in these patients (A, 25.47%; B, 37.53%; AB, 9.04%; O, 27.94%) as compared to the controls (A, 22.32%; B, 35.58%; AB, 8.83%; O, 33.25%), p-value = 0.9916 and 0.2778 respectively. The findings of the study suggest that there seems to be no correlation between various ABO blood groups and development of cardiovascular diseases. Moreover, the prevalence of major risk factors was equal in patients with different blood groups and blood groups had no impact on development of cardiovascular pathogenesis in individual subjects.Item An Ethanol-Based Proliposome Technology for Enhanced Delivery and Improved “Respirability” of Antiasthma Aerosols Generated Using a Micropump Vibrating-Mesh Nebulizer(Chitkara University Publications, 2013-11) Abdelbary M.A. Elhissi; Jasmeet Brar; Mohammad Najlah; Simon A. Roberts; Ahmed Faheem; Kevin M.G. TaylorSalbutamol sulphate liposomes were generated using ethanolbased proliposomes followed by nebulization using an Aeroneb Pro vibrating-mesh nebulizer. The droplet size, output and fine particle fraction (FPF) of the drug incorporated in liposome formulation were compared to those of a conventional drug solution. Aerosol output was determined gravimetrically and drug output was analyzed by using high performance liquid chromatography. The potential of aerosol deposition in deep lung was evaluated using inertial impaction and laser diffraction. The effect of formulation surface tension on the aerosol performance was studied. Output and FPF were improved using liposomes compared to the conventional solution, for instance, FPF values were 57.85% and 45.81% respectively. The volume median diameter as measured by laser diffraction was respectively 3.44 μm and 3.22 μm; however, the higher FPF of the liposome formulation is justified by the lower polydispersity of its aerosol. The improved aerosol performance using liposomes was attributed to the reduction of surface tension caused by the presence of phospholipid. This is the first study that demons trates the ability of liposomes to improve the nebulized drug output and FPF.Item Development and Optimization of Fast Dissolving Tablets of Losartan Potassium Using Natural Gum Mucilage(Chitkara University Publications, 2013-11) Rohit Goyal; Manju Nagpal; Sandeep Arora; Gitika Arora DhingraCurrent research work involves preparation of fast dissolving tablets of Losartan Potassium by direct compression method using different concentrations of Plantago ovata and Lepidium sativum mucilage as natural superdisintegrants. A two factor three level (32) factorial design is being used to optimize the formulation. Nine formulation batches (A1-A9) were prepared by taking two factors as independent variables (X1- amount of Plantago ovata mucilage and X2- amount of Lepidium sativum mucilage) were taken with three levels (+1, 0, -1). All the active blends were evaluated for precompression parameters (angle of repose, bulk density, carr’s index, hausner’s ratio) and formulated tablets were evaluated for post compression parameters (hardness, friability, weight variation, wetting time, disintegration time, water absorption ratio). In vitro drug release studies were carried out using USP II dissolution apparatus for 30 min. The software Design Expert (8.0.7.1) was used for generating experimental design, modeling the response surface and calculating the statistical evaluation. Tablet parametric tests of formulation batches (A1-A9) of FDT were found within prescribed limits. DT was observed in the range from 12±2 to 58.7±2.52 sec and WT from 10.3±1.52 to 49.7±5.13 sec for formulation batches (A1-A9). More than 87% drug release was observed in all formulation batches (A1-A9) within 15 minutes. Polynomial mathematical models, generated for various response variables using multiple linear regression analysis, were found to be statistically significant (P < 0.05). Formulation A7 was selected by the design expert software which exhibited DT (22.15sec), WT (17.31sec) and in vitro drug release (100%) within 15 minutes.