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
