Raman spectroscopy for the qualitative and quantitative analysis of solid dosage forms of Sitagliptin (original) (raw)
Related papers
Journal of Pharmaceutical and Biomedical Analysis, 2011
A detailed characterisation of the performance of transmission Raman spectroscopy was performed from the standpoint of rapid quantitative analysis of pharmaceutical capsules using production relevant formulations comprising of active pharmaceutical ingredient (API) and 3 common pharmaceutical excipients. This research builds on our earlier studies that identified the unique benefits of transmission Raman spectroscopy compared to conventional Raman spectroscopy. These include the ability to provide bulk information of the content of capsules, thus avoiding the sub-sampling problem, and the suppression of interference from the capsule shell. This study demonstrates, for the first time, the technique's insensitivity to the amount of material held within the capsules. Different capsules sizes with different overall fill weights (100-400 mg) and capsule shell colours were assayed with a single calibration model developed using only one weight and size sample set (100 mg) to a relative error of typically <3%. The relative root mean square error of prediction of the concentration of API for the main sample set (nominal content 75%, w/w) was 1.5% with a 5 s acquisition time. Models built using the same calibration set also predicted the 3 low level excipients with relative errors of 5-15%. The quantity of API was also predicted (with a relative error within ∼3%) using the same model for capsules prepared with different generations of API (i.e. API manufactured via different processes). The study provides further foundation blocks for the establishment of this emerging technique as a routine pharmaceutical analysis tool, capitalising on the inherently high chemical specificity of Raman spectroscopy and the non-invasive nature of the measurement. Ultimately, this technique has significant promise as a Process Analytical Technology (PAT) tool for online production application.
Raman spectroscopy for quantitative analysis of pharmaceutical solids
Journal of Pharmacy and Pharmacology, 2007
Raman spectroscopy is experiencing a surge in interest in solid-state pharmaceutical applications. It is rapid, non-destructive, no sample preparation is required and measurements can be made in aqueous environments. It can be used for not only qualitative, but also quantitative, analysis. In this paper, the use of Raman spectroscopy for quantitative analysis of pharmaceutical solids is reviewed. The technique has been used for chemical and physical form analysis. Physical form analysis has involved quantification of polymorphism, hydrates, the amorphous form and, recently, protein conformation. Initially, simple powder systems were quantified, although this has since extended to complex pharmaceutical formulations, including tablets, capsules, microspheres and suspensions. Formulations have also been analysed through packaging. The characteristics of the technique make it ideal for process monitoring and it has been used to quantify changes in-situ during processes such as wet gran...
Handheld spectrophotometers Raman spectroscopy Spatially offset Raman scattering comparison of quantitative performances Quantitation through packaging A B S T R A C T Handheld Raman spectroscopy is actually booming. Recent devices improvements aim at addressing the usual Raman spectroscopy issues: fluorescence with shifted-excitation Raman difference spectroscopy (SERDS), poor sensitivity with surface enhanced Raman scattering (SERS) and information only about the sample surface with spatially offset Raman spectroscopy (SORS). While qualitative performances of handheld devices are generally well established, the quantitative analysis of pharmaceutical samples remains challenging.
2017
The ongoing development of anti-diabetic drugs brings a revolution in the treatment of diabetes mellitus. Dipeptidyl Peptidase-4 (DPP-4) inhibitors are considered a new class of oral anti-diabetic agents used in treatment of type 2 diabetes mellitus. Therefore, the necessity to explore and compare the existing analytical method used for estimation of such drugs either single or in combination is crucial. This review offers an overview of different HPLC-UV and spectrophotometric methods used for determination of DPP-4 inhibitors namely; sitagliptin, vildagliptin, saxagliptin, linaglitpin and alogliptin in a tabulated comparative way. In addition, the present work included stability indicating assays of the drugs and determination of their process related impurities. Spectrophotometric assays showed more facilitated, simple and cost effective methods than the reported chromatographic techniques. Furthermore, the reviewed spectrophotometric methods showed the advantages of low cost sol...
Drug stability analysis by Raman spectroscopy
Pharmaceutics, 2014
Pharmaceutical drugs are available to astronauts to help them overcome the deleterious effects of weightlessness, sickness and injuries. Unfortunately, recent studies have shown that some of the drugs currently used may degrade more rapidly in space, losing their potency before their expiration dates. To complicate matters, the degradation products of some drugs can be toxic. Here, we present a preliminary investigation of the ability of Raman spectroscopy to quantify mixtures of four drugs; acetaminophen, azithromycin, epinephrine, and lidocaine, with their primary degradation products. The Raman spectra for the mixtures were replicated by adding the pure spectra of the drug and its degradant to determine the relative percent contributions using classical least squares. This multivariate approach allowed determining concentrations in ~10 min with a limit of detection of ~4% of the degradant. These results suggest that a Raman analyzer could be used to assess drug potency, nondestru...
A REVIEW STUDY ON RAMAN SPECTROMETER AND ITS APPLICATION IN PHARMACEUTICAL INDUSTRIES
Trans stellar Journals, 2021
Raman spectroscopy is a vibrational spectroscopic approach for easily interpreting and structurally identifying tiny quantities of compounds, solids, liquids, and gases based on their distinct vibrational properties. The purpose of this study is to provide an overview of Raman spectrometers in the field of pharmaceutical analysis. How has the development of the Raman spectrometer aided the pharmaceutical industry? Detection of a wide range of placebos, medications, substances, and their structures. How do they feel about the characteristics following the reaction? This spectroscopic method is used for qualitative and quantitative analysis of trace amounts of counterfeit drugs and other illegal substances on various matrices in a non-destructive manner without extensive sample preparation. This paper also describes Raman spectroscopy, its types, and its major applications. This study also includes a brief overview of Raman spectroscopy, including theoretical approaches, evolution, and numerous techniques, which are utilized for various studies. The field of light collecting and suitable source selection for the application is at the heart of the Raman spectrometer. How may the source and its accompanying optics be beneficial for the application in question? The report also proposes research to improve and develop the flexible low-cost Raman in the pharmaceutical industry, particularly for illegal substance analysis. The Raman spectroscopy method is based on the inelastic scattering of light by materials. Light scatters in two different ways: elastically and in elastically. Where the wavelengths of scattered light are the same and different. By detecting that one can offer the structural information about the samples, the wavelength shift describes the energy transfer from one incoming photon to the molecules of the sample.
A simple, precise, accurate, economical and reliable UV spectrophotometric method has been developed for the estimation of Sitagliptin phosphate in tablet dosage form. The drug shows maximum absorption at 267 nm in water and obeys Beer's law in the concentration range of 2-10 μg /mL with good correlation coefficient (R 2 =0.9995). The results of analysis were validated by recovery studies. The recovery was found to be 99.53-100.41.The relative standard deviation was found to be < 2.0 % in all cases. The Proposed spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The proposed method can be used for the reliable quantification of Sitagliptin in bulk form and routine analysis of pharmaceutical formulations.