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Development and validation of Rp-HPLC method for the simultaneous estimation of Valsartan and Sacubitril in pharmaceutical dosage form
The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Valsartan and Sacubitril in Pharmaceutical dosage form. Chromatographic separation trials were done using three columns and four mobile phases in different ratios. Columns used are Thermosil C18 column(100mm×4.6mm)5µm, Xterra C18 column(150mm×4.6mm)5µm and Chromosil C18 column having dimension of (150mm x 4.6 mm)5µm and mobile phase used are water, methanol, acetonitrile, phosphate buffer in different logic ratios based on polarity, with mobile phase consisting of Phosphate buffer (KH2PO4 and K2HPO4) pH 3 ±0.02 pH adjusted with ortho phosphoric acid and Acetonitrile (25:75 %v/v), flow rate was adjusted to 1ml/min and detection wavelength at 254nm. The retention times of Valsartan and Sacubitril was found to be 2.589 and 3.711mins. The proposed method has been validated for accuracy, precision, linearity, robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Valsartan and Sacubitril were found in range of 0.2µg-0.6µg and 0.1µg-0.3µg and correlation coefficient were found to be 0.999 and 0.999 respectively. %RSD for intermediate precision was found to be 0.1 and 0.2, for repeatability was 0.2 and 0.5, % mean recovery for Valsartan and Sacubitril was found to be 99.77% to 100.12% respectively. The method was found to be robust even by change in the mobile phase ±5% and in less flow condition. The developed method can be successfully employed for the routine analysis of Valsartan and Sacubitril in API and Pharmaceutical dosage forms
Anthelmintic activity of leaves extracts of Olea europaea on Pheretima posthuma
Parasitic roundworms (nematodes) cause substantial morbidity and mortality in livestock animals globally and considerable productivity losses to farmers. The control of these nematodes has relied largely on the use of a limited number of anthelmintics. However, resistance to many of these anthelmintics is now widespread, and, therefore, there is a need to find new drugs to ensure sustained and effective treatment and control into the future. The present study was undertaken to evaluate the anthelmintic activity of crude aqueous, Petroleum ether, chloroform and methanol extract Olea europaea leaves using Pheretima posthuma as test worms. Single concentration (5%) of extracts was tested in the bioassay, which involved the determination of the time of paralysis (P) and time of death (D) of the worms. Piperazine citrate was included as a standard reference and distilled water as a control. The results of the present study indicated that Olea europaea leaves extracts were exhibited anthelmintic activity significantly when compared with the standard (Piperazine citrate) group. Further studies are in process to isolate the active principles responsible for the activity
Reconciling of Analytical method development and Validation by Utilization of HPLC for Novel Polymer and Lipid based Drug Delivery Systems
Using polymer and lipid-based drug delivery techniques, the primary objective is to enhance bioavailability, solubility, and dissolution. Studies have proven therapeutic effectiveness, stability, toxicity, and illness detection. This research aims to show how HPLC may be used to measure novel polymer and lipid-based drug delivery systems. As explained in this article, HPLC is one of the most widely used techniques for assessing drug concentration in lipid and polymer formulations under a range of physical conditions. Because HPLC may be used with some detectors and columns, it might be challenging for researchers to find the ideal conditions to develop a simple, sensitive, and repeatable process for their lipid and polymer matrices study. The goal of this review paper is to provide researchers with information on a range of HPLC techniques used in lipid and polymer drug delivery systems
Elucidating Protein Aggregation in Neurodegeneration Diseases Using Computational Approaches
The generation of toxic non-native protein conformers has emerged as a unifying thread among disorders such as Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis. Atomic-level detail regarding dynamical changes that facilitate protein aggregation, as well as the structural features of large-scale ordered aggregates and soluble non-native oligomers, would contribute significantly to current understanding of these complex phenomena and offer potential strategies for inhibiting formation of cytotoxic species. However, experimental limitations often preclude the acquisition of high-resolution structural and mechanistic information for aggregating systems. Computational methods, particularly those combine both all-atom and coarse-grained simulations to cover a wide range of time and length scales, have thus emerged as crucial tools for investigating protein aggregation. Here we review the current state of computational methodology for the study of protein self-assembly, with a focus on the application of these methods toward understanding of protein aggregates in human neurodegenerative disorders
Medicinal properties of Abutilon indicum
Abutilon indicum is a common Indian shrub, belonging to the family Malvaceae; Also known as Mallow in english, Abutilon indicum is used as a medicinal plant. It has been extensively used as a traditional medicine as a laxative, emollient, analgesic, anti-diabetic, anti-inflammatory and blood tonic agent and also in the treatment of leprosy, urinary disease, jaundice, piles, relieving thirst, cleaning wounds and ulcers, vaginal infections, diarrhea, rheumatism, mumps, pulmonary tuberculosis, bronchitis, allergy, blood dysentery, some nervous and some ear problems. Various studies on the plant extract have been performed to confirm the anti-oxidant, anti-bacterial, analgesic, anti-inflammatory, anti-cancer, hepato-protective, immuno-modulatory and larvicidal activities of the plant. This plant is often used as a medicinal plant and is considered invasive on certain tropical islands. In traditional medicine, A. indicum is used as a aphrodisiac, demulcent, diuretic, laxative, pulmonary and sedative (leaves). The bark is astringent and diuretic; laxative, expectorant and demulcent (seeds); laxative and tonic, anti-inflammatory and anthelmintic (plant); analgesic (fixed oil); diuretic and for leprosy (roots). The plant is very much used in Siddha medicines. In fact, the bark, root, leaves, flowers and seeds are all used for medicinal purposes by Tamils. The leaves are also used to treat for pile complaints. The flowers are traditionally used to increase semen in men. The phytochemical analysis showed the Presence of Alkaloid, Saponins, Amino acid, Flavonoids, Glycosides and steroids. This plant exhibits several potential pharmacological activities. A review on the various studies on the plant has been provided for the purpose of understanding its medicinal properties
Present status, Standardization and safety issues with herbal drugs
Traditional medicine is an important component of the health care system throughout world. Herbal medicine is the use of medicinal plants for prevention and treatment of various diseases. It ranges from traditional and popular medicines of every country to the use of standardized and analyzed herbal extracts. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. Herbal-derived remedies need a powerful and deep assessment of their pharmacological qualities and safety issues due to the large and growing use of natural-derived substances all over the world. Based on the current situation, worldwide research on herbal medicine safety is still not broad or deep enough. For next step, more attention should be paid to researches on the toxicity and the herb-drug interaction of commonly used herb medicines, which are the most necessary and urgent work. For clinical safety monitoring, spontaneous reporting system or active pharmacovigilance is effective in identifying therapeutically relevant safety issues. In this paper, an attempt has been made to summarize the information described in scientific research conducted about Present status, Standardization and safety concerns of herbal drugs
Formulation and in-vitro evaluation of niosomal drug delivery system for aceclofenac.
In the past few decades, considerable attention has been focused on the development of new drug delivery system (NDDS). The NDDS should ideally fulfill two prerequisites. Firstly, it should deliver the drug at a rate directed by the needs of the body, over the period of treatment. Secondly, it should channel the active entity to the site of action. Conventional dosage forms including prolonged release dosage forms are unable to meet none of these. At present, no available drug delivery system behaves ideally, but sincere attempts have been made to achieve them through various novel approaches in drug delivery. The aim of present work is to develop a niosomal drug delivery system of aceclofenac. To perform drug-polymer compatibility FT-IR studies were carried out and observed that there was no interaction between the APl and excipients. 8 niosomal formulations are prepared by the thin film hydration method using the cholesterol as the phospholipid. Prepared niosomal formulations were characterized by vesicle size, shape, surface charge, entrapment efficiency, drug content and invitro drug release studies. The vesicle size, size distribution and zeta potential of the optimized formulation (F5) was found to be 65.6 nm and zeta potential was found to be -1.5mV. Size distribution curve confirms the normal size distribution of the vesicles. The % entrapment efficiency of niosomal vesicles formulations were found to be in the range of 54.18±0.59 to 92.71±0.56 and optimized formulation was found to be 92.71±0.56 and drug content of niosomes formulations (F1to F8) were determined to be in the range of 94.6 -97.8%. The pH of all topical niosomal gels were found to be in the range of 7.4±0.02 to 7.4±0.08.The best fit with higher correlation (r2> 0.99) was found with the Zero Order Release and follows Korsemeyer peppas equation for all the formulations, which means that release of Aceclofenac from the lipid bilayer vesicles were due to diffusion. The stability studies were carried out and there was no significant change found in the formulations
To evaluate safety and efficacy of tedizolid phosphate in the management of several skin infections
Tedizolid Phosphate is an oxazolidinone-class antibiotic and is used for the treatment of acute bacterial skin and skin structure infections. it is a prodrug activated by plasma or intestinal phosphatases to tedizolid following administration of the drug either orally or intravenously. Once activated, tedizolid exerts its bacteriostatic microbial activity through inhibition of protein synthesis by binding to the 50S ribosomal subunit of the bacteria. The purpose of the study was to evaluate safety and efficacy of Tedizolid phosphate and compare it with that of Lenizolid Phosphate another oxazolidinone class of drugs. The study was conducted at OMNI hospital located at dilsukhnagar, Hyderabad. 126 subjects with skin infections, who satisfied the eligibility criteria, were accrued during the study period. These patients were randomized into 2 groups, and were then evaluated according to the treatment protocol. Investigational product was then administered to evaluate safety and efficacy parameters. Subjects received treatment according to the study arm/group. Subjects were asked to take drug for 7 days daily once orally till the clinical symptoms disappear/ as per PIs discretion. Samples for microbiological evaluation were done at screening, end of the therapy. Among both the formulations the group the received Tedizolid phosphate was considered safer and more efficacious as Clinical success rate was 89.9% and the group that received Lenizolid phosphate had the clinical success rate of 81%. It can be concluded that Tedizolid phosphate could be promising drug in the treatment of various skin infections
Formulation and characterisation of solid lipid nanoparticle hydrogels of Naproxen
Naproxen is Non-steroidal anti-inflammatory drug (NSAID) and is considered to be first line drug in treatment of rheumatoid arthritis, osteo arthritis and ankylosing spondylitis. Naproxen undergoes first pass metabolism when taken orally and it also produces some GI problems. The aim of the study is to improve the efficacy, drug loading capacity and biocompatibility of drug by formulating in solid lipid nanoparticles. To minimize the toxicity and increase the stability of drug by encapsulating in nanoparticulate system. To optimize the developed solid lipid nanoparticle formulations. Drug Naproxen has been loaded with lipid carriers and then formulated in to Hydrogels with the objective of prolonging its action and avoiding its most side effects by incorporation of solid lipid carriers which is achieved by Nanostructured lipid carrier (NLC). Methods: Nanostructured lipid carrier was prepared by Ultra sonication or High-Speed Homogenization method. Characterization of nanostructured lipid carrier was performed by measuring particle size, drug entrapment efficiency and in-vitro drug release. Spherical uniform particles (size below 500 nm), Drug entrapment efficiency was found to be in the range of about 69-86%. The drug release profile of all the formulations after 24 h study was found to be in the range of 43%- 94%. Formulation showing sustained release profile at the end of the study was found to be the best formulation. Optimized formulation was converted in to hydrogel with Carbopol as gelling agent was formulated and characterized for its physical appearance, pH, viscosity, spreadability, homogeneity studies. Conclusion: The result concludes that Naproxen loaded nanostructured lipid carrier could be a potential drug delivery system
Pharmacoeconomic analysis of type 2 diabetes mellitus and its microvascular complications
The international society for pharmacoeconomics and outcomes research (ISPOR) defines “Pharmacoeconomics as the field of study that evaluates the behaviour of individuals, firms and markets relevant to the use of pharmaceutical products, services and programs and which frequently focuses on the costs (inputs) and consequences (outcomes) of that use”. It is the description and analysis of the cost of drug therapy to health care systems and society. This prospective observation study was carried out for over a period of 6 months commencing from March 2014 to August 2014 among inpatients of General medicine and Nephrology departments of a tertiary care referral hospital in kerala.All diabetes mellitus patient treated in the Inpatient department of General medicine and Nephrology department during March-August 2014 were monitored, collect relevant data and entered into the data sheet. Based on the inclusion and exclusion criteria of the protocol approved by the IEC, patients belonging to the age group 40-70 of both sex were selected and enrolled for the study