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\def\citeauthor{~Srikanth~A,
              ~Bhavanasi~Mounika,
              ~Vonteru~Muni~Sekhar}
\def\citetitle{\textbf{Determination of Ergotamine Tartrate and Caffeine Simultaneously in their Formulation}}
\def\copyrightstmt{This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.}
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\begin{document}


\def\RunningAuthor{Srikanth A et al.}
\firstPage{1}
\articleType{Original Article}
\receivedDate{05 Oct 2022}
\acceptedDate{29 Oct 2022}
\revisedDate{28 Oct 2022}
\journalVolume{3}
\journalIssue{1}
\journalDoi{fjphs.v3i1.333}
\copyrightYear{2023}
\eISSN{2583-116X}
\journalDoi{fjphs.v3i1.333}
\def\authorCount{3}
\def\affCount{3}

\def\journalTitle{Future Journal of Pharmaceuticals and Health Sciences}

\title{\textbf{Determination of Ergotamine Tartrate and Caffeine Simultaneously in their Formulation}}
\author{Srikanth~A\textsuperscript{*}\textsuperscript{1}\textsuperscript{\href{https://orcid.org/0000-0001-9245-7152}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}},  
            Bhavanasi~Mounika\textsuperscript{2}\textsuperscript{\href{https://orcid.org/0000-0001-9376-3215}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}}, 
            Vonteru~Muni~Sekhar\textsuperscript{3}\textsuperscript{\href{https://orcid.org/0000-0002-1703-0199}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}}~\\[5pt]{\textsuperscript{1}Department of Pharmaceutical Analysis, Vasavi Institute of Pharmaceutical Sciences, Vasavi Nagar, Peddapalli (Village), Sidhout (Mandal), Kadapa (Dist) - 516247, Andhra Pradesh, India}~\\{\textsuperscript{2}Department of Pharmaceutical Analysis, Sri Padmavathi Mahila Visvavidyalayam, Padmavathi Nagar, Tirupati {\textendash} 517502, Andhra Pradesh, India}~\\{\textsuperscript{3}Department of Pharmaceutical Analysis, Vagdevi College of Pharmacy and Research Centre, Brahmadevam Village, Muthukur Mandal, SPSR Nellore - 524 346, Andhra Pradesh, India}}

\begin{abstract}
There are numerous additional benefits of caffeine, and the most popular one is to increase mental alertness. For the treatment of migraine headaches, caffeine is taken orally or injected together with ergotamine and medicines such as aspirin and acetaminophen. A group of drugs known as ergot alkaloids includes ergotamine. It acts in conjunction with coffee by inhibiting the enlargement of blood vessels in the head that cause headaches. Specific forms of headaches are treated or prevented with this combination of medications (vascular headaches, including migraine and cluster headaches). The UV-Visible Spectrophotometric technique for simultaneous assessment of caffeine and ergotamine in the tablet dosage form in the solvent system of methanol and distilled water in a 1:1 ratio provides an accurate estimate of the \% label claim of a marketed product (Cafergot).
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Ergotamine Tartrate,\newline Caffeine
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Srikanth~A~\\ Phone:\ +91 9966599337~\\  Email:\ sreemuni12@gmail.com
        \par}\vspace*{-13pt}\hrulefill\par\ifx\@eISSN\@empty\else{\fontsize{12}{14}\selectfont eISSN: \@eISSN\hfill pISSN: \@pISSN}\par\fi% 
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        \makeatother
        
    
\section{Introduction}
Although it has numerous additional purposes, caffeine is most frequently used to increase mental alertness. For migraine headaches, caffeine is administered orally or rectally, with medicines (such as aspirin and acetaminophen) and a substance called ergotamine \unskip~\cite{1565789:26265459,1565789:26265468}. Additionally, it is used with opioids to treat and prevent migraines following epidural anesthesia and primary headaches. One of the most popular stimulants among athletes is caffeine. The National Collegiate Athletic Association permits the use of caffeine within specific parameters (NCAA). Urine with a concentration of more than 15 mg/mL is forbidden. The average person needs roughly 8 cups of coffee with 100 mg of caffeine each to obtain this urine content. In the form of a tablet under the trade name CAFERGOT, ergotamine tartrate and caffeine are used to prevent and cure migraine headaches. The drug ergotamine tartrate belongs to the group of drugs known as ergot alkaloids. Together with coffee, it prevents headaches by limiting the growth of blood vessels in the head. This combo drug treats or contains specific forms of headaches (vascular headaches, including migraines and cluster headaches). Sometimes, enlarged blood vessels in the brain might produce headache discomfort. To operate, these enlarged blood arteries are constricted by ergotamine tartrate \unskip~\cite{1565789:26265455,1565789:26265461}.

\textbf{Reagents}

Along with triple-distilled water, all the components used in this experiment were of analytical quality. Both caffeine and ergotamine tartrate were purchased from S.D. Fine Chem Ltd.

\textbf{Apparatus}

A Jasco Spectrophotometer, Model-V-630 (Japan), with a spectral bandwidth of 1 nm and wavelength precision of \ensuremath{\pm}0.3 nm with automated wavelength  


\begin{table*}[!htbp]
\caption{\boldmath {Recovery and Assay Analysis} }
\label{tw-e2d7efc220ac}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.3884\linewidth-2\tabcolsep}p{\dimexpr.4064\linewidth-2\tabcolsep}p{\dimexpr.20520000000000003\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  & \cAlignHack Ergotamine Tartarate & \cAlignHack Caffeine\\
\tblmidrule 
\cAlignHack Amount used &
  \cAlignHack 50\ensuremath{\mu}g &
  \cAlignHack 5\ensuremath{\mu}g\\
\cAlignHack Amount recovered &
  \cAlignHack 49.58\ensuremath{\mu}g &
  \cAlignHack 4.97\ensuremath{\mu}g\\
\cAlignHack Percentage recovered &
  \cAlignHack 99.16\% &
  \cAlignHack 99.4\%\\
\cAlignHack Label Claim &
  \cAlignHack 500mg &
  \cAlignHack 50mg\\
\cAlignHack Estimated &
  \cAlignHack 495.93mg &
  \cAlignHack 49.21mg\\
\cAlignHack Percentage &
  \cAlignHack 99.18\% &
  \cAlignHack 98.42\%\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {LOD and LOQ Analysis} }
\label{tw-bfc59214ab64}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.15120000000000001\linewidth-2\tabcolsep}p{\dimexpr.30380000000000003\linewidth-2\tabcolsep}p{\dimexpr.33089999999999996\linewidth-2\tabcolsep}p{\dimexpr.2141\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack S. no. & \cAlignHack Parameters & \cAlignHack Ergotamine Tartarate & \cAlignHack Caffeine\\
\tblmidrule 
\cAlignHack 1 &
  \cAlignHack Max(nm) &
  \cAlignHack 277nm &
  \cAlignHack 281nm\\
\cAlignHack 2 &
  \cAlignHack Linearity range &
  \cAlignHack 16-40\ensuremath{\mu}g/ml &
  \cAlignHack 17-42\ensuremath{\mu}g/ml\\
\cAlignHack 3 &
  \cAlignHack Regression equation &
  \cAlignHack Y=0.0512x - 0.1095 &
  \cAlignHack Y=0.0232x - 0.0013\\
\cAlignHack 4 &
  \cAlignHack Correlation coefficient &
  \cAlignHack 0.9827 &
  \cAlignHack 0.9594\\
\cAlignHack 5 &
  \cAlignHack Limit of detection &
  \cAlignHack 10.5187\ensuremath{\mu}g/ml &
  \cAlignHack 10.46\ensuremath{\mu}g/ml\\
\cAlignHack 6 &
  \cAlignHack Limit of quantification &
  \cAlignHack 31.8750\ensuremath{\mu}g/ml &
  \cAlignHack 31.6810\ensuremath{\mu}g/ml\\
\cAlignHack 7 &
  \cAlignHack Intra day &
  \cAlignHack 0.8788\ensuremath{\pm}0.0409 &
  \cAlignHack 0.9119\ensuremath{\pm}0.0518\\
\cAlignHack 8  &
  \cAlignHack Interday &
  \cAlignHack 0.8428\ensuremath{\pm}0.0089 &
  \cAlignHack 0.8720\ensuremath{\pm}0.0161\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
correction, was used for the spectral analysis. Glassware used in each step was thoroughly cleaned with double-distilled water before being dried in a hot air oven after being soaked overnight in a solution of chromic acid and sulphuric acid.
    
\section{METHODOLOGY}
\textbf{Linearity }

Working standard solutions of caffeine and ergotamine tartrate were taken in various 10-ml volumetric flasks and diluted with distilled water up to the mark to produce concentrations of 2, 4, 6, 8, and 10\ensuremath{\mu}g/ml caffeine and 50, 60, 70, 80, and 90\ensuremath{\mu}g/ml ergotamine. A calibration curve was created by graphing concentration vs absorbance, and line equations were computed for both medications \unskip~\cite{1565789:26265469}.

\textbf{Preparation of Stock Solution }

Ergotamine tartrate (10 mg) and caffeine (10 mg) were accurately weighed and transferred to two separate 100 ml volumetric flasks, where they were dissolved in 50 ml of methanol to reach the desired volume. Ergotamine and caffeine were 100 \ensuremath{\mu}g/ml in a stoke solution \unskip~\cite{1565789:26265458}.

\textbf{Preparation of Working Standard }

Wavelength selection for detection Drug solution scans were performed between 200 and 400 nm. Ergotamine tartrate and caffeine both had significant absorption at 277 and 281 nanometers, respectively, hence those wavelengths were chosen for detection. To produce the working standard for both solutions, dilute the needed amount of the 100 g/ml stock solutions of caffeine and ergotamine tartrate.

\textbf{Precision}

The ergotamine tartrate (60 \ensuremath{\mu}g/ml) and caffeine (4 \ensuremath{\mu}g/ml) responses were estimated five times for the repeatability investigations, and the data are shown as the relative standard deviation. By calculating the equivalent answers three times on the same day and three separate days for three different concentrations of ergotamine (50,60,70 \ensuremath{\mu}g/ml) and caffeine (4,6,8 \ensuremath{\mu}g/ml), the intermediate precision was performed. The findings are provided in terms of relative standard deviation \unskip~\cite{1565789:26265456}.

\textbf{Accuracy }

To assess the method's accuracy, recovery experiments of caffeine and ergotamine tartrate were conducted at three distinct levels (80\%, 100\%, and 120\%). The average recovery \% was calculated. Table~\ref{tw-e2d7efc220ac}  displays the calculated recovery values.

\textbf{Assay of Drug Formulation }

The Weight Variation Test was carried out following I.P. using tablets containing 500mg of caffeine hydrochloride and 5 mg of ergotamine tartrate. These 20 pills were precisely measured and pulverized. A 100ml volumetric flask was filled with a combination of 50ml methanol and 50ml distilled water, along with tablet powder containing 10mg of ergotamine and caffeine. After 30 minutes of sonication, filter the solution. The percentage content of the medicines has been determined from this solution, and a functional solution has been prepared \unskip~\cite{1565789:26265463,1565789:26265464}.

\textbf{Detection Limit}

The lowest quantity of analytical in a sample that can be identified is not necessarily quantitative, as an exact number is the detection limit of a particular analytical process. LOD = 3.3\ensuremath{\sigma  }/S, Where S is the calibration curve's slope and the response's relative standard deviation.

\textbf{Quantitative Limit}

The quantitation limit of an analytical process is the lowest amount of analyte in a sample that can be quantitatively determined with enough precision and accuracy. LOQ = 10\ensuremath{\sigma  }/S, Where S is the calibration curve's slope and the response's relative standard deviation.
    
\section{RESULTS AND DISCUSSION}
According to ICH criteria, the UV-Visible Spectrophotometric technique for simultaneous quantifying caffeine and ergotamine tartrate was straightforward and practical with reasonable accuracy, precision, LOD, and LOQ [Table~\ref{tw-bfc59214ab64}]. 

The method worked well for identifying medicines in their pharmaceutical formulation. The sample recoveries in all formulations utilising the aforementioned approach were in good agreement with the corresponding label claim or theoretical drug content, indicating the validity of the method and the absence of excipient interference in the estimation. 

Drugs remained stable in the chosen solvent system of methanol and distilled water for more than 48 hours, indicating that samples do not need to be estimated right away [Table~\ref{tw-e2d7efc220ac}].
    
\section{CONCLUSION}
The proposed UV-Visible Spectrophotometric technique accurately calculates the \% label claim for the marketed product Cafergot while simultaneously measuring ergotamine tartrate and caffeine in the tablet dosage form in the methanol solvent system distilled water.
    
\section{ACKNOWLEDGEMENT}
I want to thank my esteemed Principal (Dr. Venkata Gopala Krishna Sunku) at Vasavi Institute of Pharmaceutical Sciences, Vasavi Nagar, Peddapalli (V), Sidhout (M), Kadapa (Dist), Andhra Pradesh, 516247, India.\textbf{\space }

\textbf{Conflict of Interest}

The authors declare no conflict of interest, financial or otherwise.

\textbf{Funding Support}

The authors declare that they have no funding for this study.
    

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