Stability indicating RP-HPLC method development and validation for the simultaneous estimation of ceftriaxone and tazobactum in sterile powder for injection

A simple, rapid, precise and accurate method is developed for the quantitative simultaneous determination of ceftriaxone and tazobactum in bulk and pharmaceutical formulations. Separation of ceftriaxone and tazobactum was successfully achieved by using Inertsil C18 ODS column 250X4.6mm, 5µm in an isocratic mode using water and acetonitrile (80:20) at a flow rate of 1.0 ml/min and was monitored at 254 nm with a retention time of 3.049 minutes and 4.317 minutes for ceftriaxone and tazobactum respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/ml to 80 µg/ml for ceftriaxone and 5 µg/ml to 35 µg/ml for tazobactum. The values of the correlation coefficient were found to be 0.999 for ceftriaxone and 0.999 for tazobactum respectively. The LOD and LOQ for ceftriaxone were found to be 0.021 and 0.064 respectively. The LOD and LOQ for tazobactum were found to be 0.030 and 0.091 respectively. The percentage recovery for ceftriaxone and tazobactum were found to be 98-102% respectively which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.  Stability of the drugs was determined by using acid/base, thermal, oxidative stress testing

Method development and method validation of guaifenesin and dextromethorphan by RP-HPLC

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Guaifenesin and Dextromethorphan was successfully achieve THERMO, C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1M KH2PO4: Methanol (60:40) at a flow rate of 1.0ml/min and eluate was monitored at 280nm, with a retention time of 3.259 and 4.164 minutes for Guaifenesin and Dextromethorphan respectively. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Guaifenesin and 50µg/ml to150 µg/ml for Dextromethorphan. The values of the correlation coefficient were found to 0.999 for Guaifenesin and 1for Dextromethorphan. respectively. The LOD and LOQ for Guaifenesin were found to be 0.597 and 1.991 respectively. The LOD and LOQ for Dextromethorphan were found to be 0.1072 and 0.3572 respectively. This method was found to be good percentage recovery for were found to be 99 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness

A robust stability indicating HPLC technique for evalution of Pibrentasvir and Glecaprevir in tablet dosage form

When liver cells gets infected and vandalized, the condition is termed as Hepatitis. HCV therapy is performed with mixture of drugs. For the combined evaluation of Pibrentasvir and Glecaprevir in tablets, a rapid, selective and robust HPLC technique stability indicating was developed herein this work. Analysis was executed by Cosmicsil, with dimensions 250 mm by 4.6 mm column and mobile phase possessing KH2PO4 with 0.1M, 65 ml and 35 ml of methanol and 230 nm of PDA analysis. Elution times were found out as were 1.663 min and 2.249 min, for Pibrentasvir and Glecaprevir respectively with linear ranges 20µg/ml, 60 µg/ml and 50 µg/ml, 150 µg/ml, respectively having detection limits as 0.190 µg/ml and 0.207  µg/ml and quantization limits as 0.634 µg/ml and 0.690 µg/ml. This method is explicit having RSD values as 0.097% Pibrentasir & 0.232% Glecaprevir showing an accuracy of between 98.82 and 100.07% for Pibrentasir 99.31, Glecaprevir 100.45% recovery values. During the investigation of degradation, peaks elution times of degradants greatly varied with the elution times of Glecaprevir and Pibrentasvir thus, proving method‘s power of stability indication and specificity. The validation and degradation stability studies were carried out according to ICH and ICH Q1B Guidelines

Influence of different storage temperatures and packing material in extending shelf life and quality attributes of palmyrah (Borassus flabellifer L.) neera

Palmyrah neera (inflorescence sap) is susceptible to natural fermentation at ambient temperature within a few hours of extraction due to enzymatic and microbial activity. Once fermented, neera becomes toddy which is unsuitable as a health drink or as a value-added product. Therefore, a study was carried out to investigate the influence of different packing materials and storage conditions on the shelf life and to keep the quality of palmyrah neera. The experiment was conducted in a completely randomised factorial design with two factors at unequal levels replicated thrice. HDPE 50 micron pouch (P1), PET bottle (P2) and glass bottle (P3) and cold storage at 2 oC (S1), cold storage at 4 oC (S2) and refrigerated storage (8-10 oC) (S3) were the packing material and storage conditions respectively used during experimentation. Physio-chemical properties viz., total soluble solids, pH and reducing sugars showed an increasing trend up to the 4th week of storage. At the same time, phenols, titrable acidity and alcohol content increased up to the 6th week of storage. Maximum total soluble solids (10.80 oBrix), reducing sugars (5.76%), minimum phenolic content (0.323 mg) and titrable acidity (1.116%) were recorded when palmyrah neera was packed in HDPE 50 micron pouch, whereas the maximum total soluble solids (10.83oBrix), reducing sugars (5.75%), minimum phenolic content (0.322 mg) and titrable acidity (1.14%) were recorded when palmyrah neera was stored at 2 oC. Among the different packing material and storage conditions, HDPE 50 micron and storage at 2 oC was effective in extending the shelf life and quality attributes of palmyrah neera

Colorimetric method for determination of corticosteroids by UV Visible Spectroscopy and its application to Ayurvedic formulations

Usage of herbomineral preparations increased drastically these days. Some of the Ayurvedic formulations are been adulterated with steroids. Usage of such formulations can be injurious to health. Hence an attempt has been made to identify and determine steroids in both Ayurvedic and pharmaceutical formulations. In the present study a simple, sensitive and economical visible spectroscopic method has been used which involves the oxidation of corticosteroids by iron(III) and subsequent complexation of iron(II) with potassium  hexacyanoferrate (III), forming bluish green colored complex having the maximum absorbance at 780 nm. The method has been applied for the determination of corticosteroids in Ayurvedic formulations. The method has been statistically validated in which the  Standard deviation ranging  from  0.0008 to 0.0135,Relative standard deviation from 0.08% to 1.35% and Standard error was varying from 0.0018 to 0.0060 for selected Ayurvedic formulations. The studies have shown that the method is fast, reproducible and accurate and can be used in the analysis of marketed formulations. The processed samples were stable up to 2 hours minimizing the error in terms of fluctuating absorbance values

Filthy operative rooms and other mistakes during movies on neurosurgical procedures: Fascinating and powerful neurosurgical scenarios presented, in different ways, to non-neurosurgical society. How many mistakes and stereotypes can be made in movies for people not daily involved in medical life?

Objectives: The brain and people “manipulating” it, provide a very mysterious and fascinating substrate for a movie. Faithful representation of reality often represent a key for the success of a film. Nonetheless, while watching movies with neurosurgical scenes, we often observed actions and elements containing incredible errors that aroused opposing emotions. The aim of this study was to perform an extensive review examining the representations of neurosurgery in movies, especially focused on the analysis of neurosurgical gross mistakes. Patient and methods: We looked for any movie that featured a neurosurgeon or a scene including a neurosurgical disease or procedure. We used one of the largest internet movie databases available online (IMDb.com) with searching for keywords such as “neurosurgeon”, “neurosurgery”, and “craniotomy”. Title, year, genre and cost of production were collected. The first three features were detected on IMDb.com; the costs of production were found in websites the-numbers.com and boxofficemojo.com. Analysis and selection were performed by AM and PDB. Result: 73 movies were found. After the application of inclusion/exclusion criteria, 58 have been eligible for inclusion in the study (Table 1) and 15 have been excluded from the final analysis”. Out of 45 movies watched, we found 32 neurosurgical mistakes. Mistakes were classified into four big groups, namely: “surgical asepsis and principles of sterile technique” (n = 13, 40 %); “conceptual mistakes (n = 10, 31.5 %)”; “incorrect use of surgical tools (n = 7, 22 %)”; “anatomical and radiological mistakes (n = 2, 6.5 %)”. The costs of production started from 11.000 US dollars (Vsivaci, 2014) to 200 millions dollars (Spiderman 2, 2004), with a median value of 8.2 millions dollars each. All mistakes were not useful for the correct progress of the movie. Conclusion: Our review shows that several mistakes, especially on asepsis during surgery are present in films dealing with neurosurgery. Several movies costed up to millions of dollars. Would a consultation of a Neurosurgeon before/during the shooting narrow the gap between the reality and fiction

Quantitative MRI reveals differences in striatal myelin in children with DLD.

Developmental language disorder (DLD) is a common neurodevelopmental disorder characterised by receptive or expressive language difficulties or both. While theoretical frameworks and empirical studies support the idea that there may be neural correlates of DLD in frontostriatal loops, findings are inconsistent across studies. Here, we use a novel semiquantitative imaging protocol - multi-parameter mapping (MPM) - to investigate microstructural neural differences in children with DLD. The MPM protocol allows us to reproducibly map specific indices of tissue microstructure. In 56 typically developing children and 33 children with DLD, we derived maps of (1) longitudinal relaxation rate R1 (1/T1), (2) transverse relaxation rate R2* (1/T2*), and (3) Magnetization Transfer saturation (MTsat). R1 and MTsat predominantly index myelin, while R2* is sensitive to iron content. Children with DLD showed reductions in MTsat values in the caudate nucleus bilaterally, as well as in the left ventral sensorimotor cortex and Heschl's gyrus. They also had globally lower R1 values. No group differences were noted in R2* maps. Differences in MTsat and R1 were coincident in the caudate nucleus bilaterally. These findings support our hypothesis of corticostriatal abnormalities in DLD and indicate abnormal levels of myelin in the dorsal striatum in children with DLD

Microstructural Properties of the Cerebellar Peduncles in Children With Developmental Language Disorder

Abstract Children with developmental language disorder (DLD) struggle to learn their native language for no apparent reason. While research on the neurobiological underpinnings of the disorder has focused on the role of corticostriatal systems, little is known about the role of the cerebellum in DLD. Corticocerebellar circuits might be involved in the disorder as they contribute to complex sensorimotor skill learning, including the acquisition of spoken language. Here, we used diffusion-weighted imaging data from 77 typically developing and 54 children with DLD and performed probabilistic tractography to identify the cerebellum’s white matter tracts: the inferior, middle, and superior cerebellar peduncles. Children with DLD showed lower fractional anisotropy (FA) in the inferior cerebellar peduncles (ICP), fiber tracts that carry motor and sensory input via the inferior olive to the cerebellum. Lower FA in DLD was driven by lower axial diffusivity. Probing this further with more sophisticated modeling of diffusion data, we found higher orientation dispersion but no difference in neurite density in the ICP of children with DLD. Reduced FA is therefore unlikely to be reflecting microstructural differences in myelination, rather the organization of axons in these pathways is disrupted. ICP microstructure was not associated with language or motor coordination performance in our sample. We also found no differences in the middle and superior peduncles, the main pathways connecting the cerebellum with the cortex. To conclude, it is not corticocerebellar but atypical olivocerebellar white matter connections that characterize DLD and suggest the involvement of the olivocerebellar system in speech and language acquisition and development.</jats:p

A Randomized Controlled Trial of Increased Dose and Frequency of Albendazole with Standard Dose DEC for Treatment of <i>Wuchereria bancrofti</i> Microfilaremics in Odisha, India

<div><p>Although current programmes to eliminate lymphatic filariasis have made significant progress it may be necessary to use different approaches to achieve the global goal, especially where compliance has been poor and ‘hot spots’ of continued infection exist. In the absence of alternative drugs, the use of higher or more frequent dosing with the existing drugs needs to be explored. We examined the effect of higher and/or more frequent dosing with albendazole with a fixed 300mg dose of diethylcarbamazine in a <i>Wuchereria bancrofti</i> endemic area in Odisha, India. Following screening, 104 consenting adults were randomly assigned to treatment with the standard regimen annually for 24 months (S1), or annually with increased dose (800mg albendazole)(H1) or with increased frequency (6 monthly) with either standard (S2) or increased (H2) dose. Pre-treatment microfilaria counts (GM) ranged from 348 to 459 mf/ml. Subjects were followed using microfilaria counts, OG4C3 antigen levels and ultrasound scanning for adult worm nests. Microfilarial counts tended to decrease more rapidly with higher or more frequent dosing at all time points. At 12 months, Mf clearance was marginally greater with the high dose regimens, while by 24 months, there was a trend to higher Mf clearance in the arm with increased frequency and 800mg of albendazole (76.9%) compared to other arms, (S1:64%, S2:69.2% & H1:73.1%). Although higher and/or more frequent dosing showed a trend towards a greater decline in antigenemia and clearance of “nests”, all regimens demonstrated the potential macrofilaricidal effect of the combination. The higher doses of albendazole did not result in a greater number or more severe side effects. The alternative regimens could be useful in the later stages of existing elimination programmes or achieving elimination more rapidly in areas where programmes have yet to start.</p></div