Development and Validation of Stability Indicating RP-UPLC Method for Determination of Related Substances of Cinacalcet Tablets

INTRODUCTION: Analytical Chemistry is the oldest branch of Chemistry and is the foundation block on which other branches, namely, inorganic, organic, physical and biochemistry have grown to their present level. Understanding of these branches would not have been possible without an understanding and application of principles of analytical chemistry. It has provided us a glimpse of matter from simple atomic structures to complex molecules to comprehend properties based on structural arrangements. We have gained insight into the origin and evolution of the universe and life on our own planet through application of analytical techniques. An understanding of composition has contributed to improvement of material characteristics of natural resources and industrial materials to the benefit of mankind. Today we cannot think of even a single product of commercial use which has not been tested using analytical chemistry techniques before clearance for consumption Earliest studies were mainly concerned with understanding the composition of environment and natural resources based on classical methods of analysis. Classical Analysis also known as wet chemistry introduced quantitative studies and to this day forms the backbone of most university and industrial laboratories. Earliest techniques were by and large gravimetric in nature with the objective of determination of elemental composition. Titration methods evolved subsequently for acid-base and metals analysis of solutions. Analytical Chemistry is poised to make even greater contributions to betterment of life and understanding of new materials. AIM AND OBJECTIVE: The aim of the study is to develop simple, novel methods for the Determination of related substances of Cinacalet in bulk and pharmaceutical dosage forms. The estimation of Cinacalcet impurities in degraded product have been reported and review of literature indicated that no validated analytical method have been reported for pharmaceutical formulation till date. The objective of the present work is to develop analytical methods for the estimation of related substances in Cinacalcet tablets which comprises of the following. Reverse Phase -Ultra Performance Liquid Chromatographic Method (RP-UPLC) SUMMARY AND CONCLUSION: The present work entitled “Development and validation of stability indicating RP-UPLC method for determination of Related substances of Cinacalcet tablets” comprises of the following novel methods which have not been reported till date. Reverse phase-Ultra Performance Liquid Chromatography (RP-UPLC) The ultra violet method involves the determination of Related substances of Cinacalcet tablets 90mg by External standard method. The drug obeyed Beer’s Law at the concentration of 5-30 μg/mL. The correlation co-efficient was found to be 0.99 for the methods. The low percentage RSD value shows that the methods developed are not affected by the presence of sample matrix or devoid of interference by the excipients. In RP-UPLC method, C18column was used for estimation of impurities of Cinacalcet tablets. By trial and error method mobile phase chosen was Mobile phase A-0.1%v/v orthophosphoric acid and Mobile phase-B-Acetonitrile: Methanol (40.:60%v/v) and the effluents were monitored at 210nm for cinacalcet and its related compounds. The retention time was about 9.3. The chromatograms were then subjected to system suitability studies. The tailing factor and asymmetry factor were close to 1.2 which showed ascertained of the peak. The number of theoretical plate was found to be 355529 which proved the efficiency of the column. The correlation coefficient indicated linearity of the method. The %RSD values were < 10 which showed the reproducibility and specificity of the method and it can be used for routine analysis. The RP-UPLC method developed for determination of related substance of cinacalcet tablets 90mg is simple, accurate, precise rapid economical and stability indicating. The RP-UPLC methods though utilizes costly equipment is more accurate and highly specific and well suitable for more number of sample analysis and simultaneous estimation of drugs. The run time (27 min) enables for rapid determination of impurities . The method was validated for accuracy, precision, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of Cinacalcet and its impurities. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase showed that the method is suitable for routine quantification of impurities in Cinacalcet in pharmaceutical dosage forms with high precision and accuracy. Moreover, it may be applied for determination of Cinacalcet in the study of blend uniformity, tablet content uniformity and in-vitro dissolution profiling of Cinacalcet dosage forms, where sample load is higher and high throughput is essential for faster delivery of results Therefore all the proposed validation methods could be used for routine analysis and are devoid of interference by sample excipients

Evaluation of physicochemical characteristics and antimicrobial activities of copper oxide nanoparticles formed by the solution combustion method

In this paper, copper oxide (CuO) nanoparticles (NPs) was prepared by solution combustion technique. We used copper nitrate as an oxidizer and malic acid as a fuel to make three different CuO NPs by using different fuel ratios: low (M1), stoichiometric (M2), and high (M3). The XRD patterns show that the CuO NPs have the monoclinic structure with an average grain size of 17, 20, and 18 nm corresponding to M1, M2, and M3 respectively. The SEM images revealed that the CuO NPs prepared display bush as morphology consisting of a wheat-like structure for M1, rod-like structure for M2, and sheet-like structure for M3 sample. The FTIR spectrum shows that CuO NPs is successfully formed in all of the samples. A bandgap of around 3.26 eV can be seen in the UV-Vis spectrum. Also, the three samples are possessing antibacterial activity and are influenced by the crystalline size, shape, purity, and uniformity of the crystals. Among the three samples with a difference of morphology, the most influencing factor of antibacterial activity being the shape that of other larger-sized particles

Synthesis and characterization of CuO nanowires by a simple wet chemical method

We report a successful synthesis of copper oxide nanowires with an average diameter of 90 nm and lengths of several micrometers by using a simple and inexpensive wet chemical method. The CuO nanowires prepared via this method are advantageous for industrial applications which require mass production and low thermal budget technique. It is found that the concentration and the quantity of precursors are the critical factors for obtaining the desired one-dimensional morphology. Field emission scanning electron microscopy images indicate the influence of thioglycerol on the dispersity of the prepared CuO nanowires possibly due to the stabilization effect of the surface caused by the organic molecule thioglycerol. The Fourier transform infrared spectrum analysis, energy dispersive X-ray analysis, X-ray diffraction analysis, and X-ray photoemission spectrum analysis confirm clearly the formation of a pure phase high-quality CuO with monoclinic crystal structure

INVESTIGATION ON GROWTH AND CHARACTERIZATION OF NONLINEAR OPTICAL DICHLORO-DIGLYCINE ZINC II SINGLE CRYSTAL

The study of amino acid based nonlinear optical (NLO) materials with optimum physical properties is an important area due to their practical applications such as optical communication, optical computing, optical information processing, optical disk data storage, laser fusion reactions, laser remote sensing, colour display, medical diagnostics, etc. Also, microelectronic industries require crystals which possess low dielectric constant at higher frequency. Keeping this in view, attempts have been made to grow nonlinear optical crystals and study their optical, electrical and mechanical properties. Nonlinear optical single crystals of dichloro-diglycine zinc II have been grown by slow evaporation method. The grown crystals were characterized using single crystal X-ray diffraction, Fourier transform infrared spectroscopy (FTIR), UV-VIS-NIR spectrum, thermal, mechanical and dielectric studies. The results of characterization studies have been discussed in detail to understand their properties. The grown crystals have better thermal stability and sufficient mechanical strength. They are capable of inducing polarization due to dielectric behaviour when powerful laser beam is incident on them. The various characterization studies suggest that the grown crystals are promising materials for optoelectronic and nonlinear optical applications

Evaluation of photocatalytic activity of copper ferrite nanoparticles

The research expresses a simple green genesis approach to synthesize copper ferrite (Cu2Fe2O4) nanoparticles using copper sulphate (CuSO4) along with ferrous sulphate (FeSO4). The investigation has been made to do photocatalytic decolourization of Methylene Blue dye under UV light utilizing copper ferrite. The photocatalyst was prepared from fruit peel waste such as Pomegranate, Apple, Grapes, Orange and Banana (PAGOB). The characterization of nanoparticles was done by X-ray diffraction (XRD) as well as Scanning Electron Microscope (SEM). The photodegradation rate of the dye was examined spectrophotometrically. The reaction was observed for pH, dye concentration, a dose of photocatalyst and intensity of light on the rate of photocatalytic to know the effect. Finally, the result was that the photodegradation has touched 88% under ideal conditions. © 2019 IOP Publishing Ltd

Fabrication of photocatalyst MgO: CuO composite and enhancement of photocatalytic activity under UV light

The green synthesis of composites through biological entities such as natural plants, algae, bacteria, fungi, and viruses is regarded to be easy, fast, affordable, low-cost, and environmentally friendly. Therefore, the MgO:CuO composites were synthesized by eco-friendly synthesis method. The MgO:CuO composites were prepared from many fruits of PAGOB (Pomegranate, Apple, Grapes, Orange and Banana) peel extract. The present study is decolourization of methylene blue dye using UV light. The phase purity and crystallite size were characterized and confirmed by x-ray diffraction (XRD) studies. The maximum absorbance was obtained in the 200-800 nm regions with a prominent peak absorbance was observed by UV-vis spectrum. The corresponding band gap for MgO:CuO composite was calculated using Tauc's plot and was found to be 2.2 eV. The textural and surface morphological feature of the synthesized composites were characterized by High-resolution Scanning Electron Microscopy (HR-SEM) and elemental analysis of Composites was analyzed with the help of Energy Dispersive x-ray analysis (EDX). The influence of pH, dye concentration, amount of photocatalyst and intensity of light on the rate of photocatalytic reaction was observed. The results show that the degradation reached 89% under optimum conditions. The resulting MgO:CuO composites and exhibits highly efficient and excellent photocatalytic properties. This property can be utilized to degrade organic contaminants. This concept was shown by degrading methylene blue, which can be observed photometrically. © 2019 IOP Publishing Ltd

A waste to worth approach in preparing Ferric vanadate Nanoparticles using peel extract for photocatalytic dye degradation induced by UV light

Photocatalytic decolorization of methylene blue dye (MB) under obvious light has been examined utilizing Ferric Vanadate nanoparticles (FV NPs). The photocatalyst was prepared by using various natural product peel waste (Pomegranate, Apple, Grapes, Orange and Banana (PAGOB)). The physico- and opto-chemical properties of prepared Ferric Vanadate nanoparticles (FV NPs) were determined using X-ray diffraction (XRD) and High-resolution Scanning Electron Microscope (HRSEM). UV–vis spectrophotometric analysis was used to study the rate of photocatalytic degradation of the dye measuring the optical density at regular time intervals. The factors influencing the photocatalytic degradation viz. effect of pH, the concentration of the dye, the quantity of photocatalyst (FV NPs) and the effect of light intensity on the rate of photocatalytic response was investigated under ideal conditions. The outcome demonstrates that degradation achieved 99% under ideal conditions. © 2019 Elsevier Gmb