Development and Validation of Stability Indicating RP-HPLC method for Teneligliptin Hydrobromide Hydrate

Girish D. Dahikar; Gayatri Bobade; Gaurav D. Chaudhari; Shubham D. Patil; Hemant V. Chaudhari; Dipika G. Itnare; Pratiksha J. Patil; Kalpesh V. Sonar; Parag R. Patil; Afra Mohamed; An Maria Benoy; Asha Maria Xavier; Rosmin Jacob; Reem Mohsen; Shereen Sabry; Anil Kumar; Anup S. Balte; Praveen Kumar Goyal; K. M. Sharma1 and R. R. Aggarwal; Vinayak N. Vanjeri; Naganagouda Goudar; Saraswati P. Masti; Ravindra B. Chougale; Raju Thenge; Laxmikant Mehesare; Vaibhao Adhao; Vinayak Shrikhande; Nilesh Mahajan

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February 2021 Issue 1

Volume 11, Issue 1 - $2021

Issue Details:

Volume 11 Issue 1

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Editorial: February 2021 Issue 1

Welcome to the 2021 issue of American Journal of PharmTech Research. This issue showcases the remarkable breadth and depth of contemporary research across multiple disciplines. From cutting-edge applications of machine learning in climate science to the revolutionary potential of quantum computing in drug discovery, our featured articles demonstrate the power of interdisciplinary collaboration in addressing global challenges.

We are particularly excited to present research that bridges traditional academic boundaries, reflecting our journal's commitment to fostering innovation through cross-disciplinary dialogue. The integration of artificial intelligence with environmental science, the application of blockchain technology to supply chain management, and the convergence of urban planning with smart city technologies exemplify the transformative potential of collaborative research.

As we continue to navigate an era of rapid technological advancement and global challenges, the research presented in this issue offers both insights and solutions that will shape our future. We thank our authors, reviewers, and editorial board members for their continued dedication to advancing knowledge and promoting scientific excellence.

Dr Hemangi J Patel
Editor-in-Chief
American Journal of PharmTech Research

Articles in This Issue

Showing 8 of 8 articles

Research PaperID: AJPTR111001

Development and Validation of Stability Indicating RP-HPLC method for Teneligliptin Hydrobromide Hydrate

Girish D. Dahikar, Gayatri Bobade

Teneligliptin hydrobromide hydrate is a new FDA approved drug for treatment of Diabetes Mellitus. Very few methods have been reported for its identified degradation products and their effects on human. A simple, rapid, precise and accurate stability indicating RP-HPLC method was developed and validated for identification of Teneligliptin hydrobromide hydrate and its degradants on Kromacil C18 column using pH 5.5 phosphate buffer and methanol (75:25v/v) as a mobile phase in isocratic mode of elution at a flow rate 1.2 ml/min. The column effluents were monitored by a variable wavelength UV detector at 270 nm. The method was validated as per ICH guidelines. Forced degradation studies of Teneligliptin hydrobromide hydrate were carried out under acidic, basic, neutral, peroxide, photo and thermal conditions. Degradation was observed in basic and neutral stress samples, but not in acid, peroxide, photo and thermal stress samples.

Teneligliptin hydrobromide hydrateRP-HPLCvalidationstabilitydegradation

322,315 views

96,655 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.001

Contributors:

Girish D. Dahikar

Gayatri Bobade

Research PaperID: AJPTR111002

Development and Validation of UV Spectroscopic Method for Estimation of Fosfomycin In Fosfomycin for Injection

Gaurav D. Chaudhari, Shubham D. Patil, Hemant V. Chaudhari, Dipika G. Itnare, Pratiksha J. Patil, Kalpesh V. Sonar, Parag R. Patil

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Fosfomycin in Fosfomycin for Injection. The drug is freely soluble in analytical grade water 1. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics 2. It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity 4, 5, 6. The UV spectroscopic method was developed for estimation of Fosfomycin in injection dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade water, slightly soluble in 95% Methanol and Ethanol. Almost insoluble in anhydrous acetone, ether and chlorinated solvent. So, the analytical grade water is used as a diluent in method. The melting point of Fosfomycin was found to be 94 - 95?C (uncorrected). It showed absorption maxima 254 nm in analytical grade water. On the basis of absorption spectrum the working concentration was set on 50µg/ml (PPM). The linearity was observed between 30-70 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.41%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Fosfomycin in Fosfomycin for Injection dosage form. The method could be considered for the determination of Fosfomycin in quality control laboratories.

FosfomycinUV SpectrophotometerMelting PointAssay MethodValidationAccuracy+3 more

322,472 views

96,784 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.002

Contributors:

Gaurav D. Chaudhari

Shubham D. Patil

Hemant V. Chaudhari

Dipika G. Itnare

Pratiksha J. Patil

Kalpesh V. Sonar

Parag R. Patil

Research PaperID: AJPTR111003

Statins: Preventive Measure for Cardiovascular Disease in Elderly Population

Afra Mohamed, An Maria Benoy, Asha Maria Xavier, Rosmin Jacob

Statins or HMGCoA reductase inhibitors are a group of medicine which effectively prevents cardiovascular disease due to the deposition of atherosclerotic plaques and hence the CV events in elderly population .It also possess inhibitory action on inflammation reaction, improve endothelial function and stabilize coronary plaques. Studies reveals that there is a significant decline in incidence of atherosclerotic CVD and more rigorous study is required to establish association between statin use and reduction in CVD death and all-cause mortality.

Cardiovascular Disease3-Hydroxymethyl glutaryl Coenzyme A (HMGCoA) reductase inhibitorsLow Density LipoproteinAtherosclerosisType 2 Diabetes Mellitus.

322,539 views

96,800 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.003

Contributors:

Afra Mohamed

An Maria Benoy

Asha Maria Xavier

Rosmin Jacob

Research PaperID: AJPTR111004

In Vivo Evaluation of Piroxicam Release In Cellulose Acetate Phthalate Films In and Organogels In Rats

Reem Mohsen, Shereen Sabry

Three groups of rats each consists of five rats were used for this study. Edema was induced by injecting a solution of carrageenan in saline intradermally. Transdermal cellulose acetate phthalate film (with IPM as penetration enhancer) with highest drug release and organogels formulation (Fl: Span 60: 17; Tween 20: 3; Soya bean oil: 40; Drug: 2 and Water: 40) with the highest spreadability, the lowest viscosity and the optimized drug release over 8 h was applied. Results from the in vivo pharmacological study revealed that gel preparation was superior to the patch in reducing the edematous swelling in the rats feet pad over the 1 day of application.

OrganogelsSolution of carrageenan

322,521 views

96,824 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.004

Contributors:

Reem Mohsen

Shereen Sabry

Research PaperID: AJPTR111005

Survey, Isolation and Confirmation of Bacterial Black Rot disease in cabbage in the tribal populated area of Kanke block under Ranchi district of Jharkhand state.

Anil Kumar

Black rot has been a main disease constraint of cabbage grown by farmers in Ranchi. Cabbage is popular cultivars of the species (Brassica oleracia) belong to Cruciferae family. The family cruciferae also includes tomato, cauliflower, beans, broccoli, radish, turnip and pepper. In plain area it is grown mainly as a winter crop, whereas in the hilly areas it is grown as a spring and early summer crop. Cabbage is one of the common and most popular winter vegetables grown in India. In Jharkhand the cabbage is grown almost whole year except in the months when temperature rises up to 40-45 degree Celsius. The purpose of this work was to survey, culturing of isolate from cabbage and confirming the severity of Black rot disease in cabbage in the tribal populated area of Kanke block under Ranchi district of Jharkhand state. In morphology and growth characteristics the all the three isolate resemble those describe by Patel et.al.(1949) and Pandey (1980).It is evident from this the isolates of New Zealand and three local isolates of cabbage were morphologically alike being short rod with rounded ends. They are Gram negative and show positive KOH solubility. On the basis of the possession of many phenotypic properties the three cabbage isolates have been tentatively assigned to this pathogen Xanthomonas campestris pv. Campestris (Xcc) .

CabbagediseaseBrassicaXanthomonas campestris

322,849 views

96,811 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.005

Contributors:

Anil Kumar

Research PaperID: AJPTR111006

Two New Triterpenoids from the Roots of Ficus Racemosa Linn.

Anup S. Balte, Praveen Kumar Goyal, K. M. Sharma1 and R. R. Aggarwal

Ficus racemosa Linn. is a moderate-sized avenue tree found throughout India either wild or cultivated for its fruits eaten by villagers. It is popular in Indigenous system of medicine like Ayurveda, Siddha and Homeopathy. Two new triterpenoids of lanostene series were isolated from the roots of Ficus racemosa and their structure were determined as Lanost-20-en-3β-acetate (1) and Lanost-20-en-3β-ol (2) on the basis of various spectral and chemical studies.

Ficus racemosa Linn. TriterpenoidsLanost-20-en-3?-acetate (1)Lanost-20-en-3?-ol (2)

322,577 views

96,935 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.006

Contributors:

Anup S. Balte

Praveen Kumar Goyal

K. M. Sharma1 and R. R. Aggarwal

Research PaperID: AJPTR111007

Miscibility and Thermal Study of 4-Hydroxycoumarin Doped Chitosan Films

Vinayak N. Vanjeri, Naganagouda Goudar, Saraswati P. Masti, Ravindra B. Chougale

In this study, new Chitosan/4-Hydropxycoumarin films were prepared and characterized. The influence of 4-Hydroxycoumarin on the surface morphology, thermal behavior of the chitosan films were studied. The experimental studies showed that surface morphology becomes uniform and surface roughness increases with increasing the concentration of 4-Hydroxycoumarin in the chitosan film. The appreciable intermolecular interaction among the chitosan and 4-Hydroxycoumarin is confirmed by the FTIR study. The thermal properties of the chitosan films slightly increased with the increasing concentrations of 4-Hydroxycoumarin. Also, the presence of single glass transition temperature in all Chitosan/4-Hydroxycoumarin films suggests the components present in the film were miscible. Due to the existence of 4HC into the chitosan film, the crystalline nature and water contact angle of CS decreases for the C4HC films. It can be expected that, the best properties of Chitosan/4-Hydroxycoumarin films were recorded in the study may play a vital role in food packaging and coating applications.

Surface morphologythermal behaviourglass transition temperaturemiscibility

322,958 views

96,980 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.007

Contributors:

Vinayak N. Vanjeri

Naganagouda Goudar

Saraswati P. Masti

Ravindra B. Chougale

Research PaperID: AJPTR111008

Improvement of Acid Stability of Lansoprazole by Co crystallization Techniques

Raju Thenge, Laxmikant Mehesare, Vaibhao Adhao, Vinayak Shrikhande, Nilesh Mahajan

The proton pump inhibitor are rapidly degraded in the acidic medium Thus it has less bioavailability since it is acid labile , mostly available in the enteric coated tablet to prevent acids degradation .But the onset of action is delayed. It is a great challenge to formulate simple compression solid dosage form of these drugs with considerable stability and efficacy. The Cocrystals of Lansoprazole was prepared by solvent evaporation using nicotinamide as a coformer. The prepared cocrystals were characterized by FTIR, SEM, DSC and XRD study. The cocrystals also evaluated for solubility and acid stability studies. The formation of Lansoprazole cocrystals were confirmed using FTIR, DSC showed the decreased in the melting point of cocrystals corresponds to melting point of pure Lansoprazole. The SEM also confirmed the changes in the habit of crystals. The acid stability study performed using HPLC and confirmed that the Cocrystals of Lansoprazole stable upto 75 % than the pure lansoprazole in 0.1 N HCL.

CocrystalsLansoprazoleAcid stabilityFTIRDifferential Scanning Calorimetry

323,160 views

96,883 downloads

DOI:: 10.46624/ajptr.2021.v11.i1.008

Contributors:

Raju Thenge

Laxmikant Mehesare

Vaibhao Adhao

Vinayak Shrikhande

Nilesh Mahajan

Volume 16, Issue 1Current

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Volume 15, Issue 4

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