DRUG POLYMORPHISM IDENTIFICATION USING FOURIER TRANSFORM-RAMAN SPECTROSCOPY: A COMPARATIVE STUDY OF LAMIVUDINE AND FINASTERIDE DRUGS

  • CHANDRA SEKHARA RAO M Department of Chemistry, Sri Venkateswara University, Tirupati, Andhra Pradesh, India.
  • CHENNA KRISHNA REDDY R Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Ananthapuramu, Andhra Pradesh, India.
  • CHANDRA SEKHAR KB Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Ananthapuramu, Andhra Pradesh, India.
  • RAMI REDDY YV Department of Chemistry, Sri Venkateswara University, Tirupati, Andhra Pradesh, India.

Abstract

Objectives: Maintaining the quality of the pharmaceutical drug product during its shelf life is highly desirable. The crystalline form of the drug having the great thermodynamic stability is essential for the manufacturers in pharmaceutical industry in view of their profit and also for the safety of the customer. Many pharmaceutical drugs have the tendency to exhibit polymorphism which is unwanted for pharmaceutical companies, where they have experienced market shortages due to these unpredicted polymorphic and/or pseudomorphic changes. The property of a drug exhibiting more than one crystal form is considerably regarded as polymorphism and each of the crystalline form has its own physicochemical properties, namely, solubility, heat capacity, melting point, and sublimation point. To relieve this ultimate effect on the drug quality and stability, a prior detection of polymorphism in the final dosage form is highly recommended. Hence, many analytical techniques have been proposed for the detection of polymorphism in pharmaceutical drug products.


Methods: Fourier transform (FT)-Raman spectrometer is used for the investigation of drug polymorphism and the instrument is advanced with charge coupled device detectors, ease of sample preparation and handling, mitigation of sub-sampling problems using different geometric laser irradiance patterns and having different optical components of Raman spectrometers.


Results: In this work, we carefully studied the Raman spectral patterns for Lamivudine as well as Finasteride drug substances for the detection of polymorphism. Further, we have highlighted the advantages of FT-Raman spectroscopy over other polymorphism detection techniques. For example, Raman spectra showed invariably sharp, well resolved bands compare to IR spectra due to the minor contribution of overtone vibrations in Raman spectra, resulting in much less broadening and a better resolution of bands. Besides, Raman spectroscopy does not suffer from the sampling problems that are common in X-ray powder diffraction, where preferred orientation and specimen displacements are serious restrictions for the application of quantitative method.


Conclusion: Here, in this paper, we are presented and compared the experimental results regarding the detection of polymorphism in Lamivudine and Finasteride drugs using FT-Raman spectroscopy, to illustrate the advantages of the technique in the detection of polymorphism over other techniques.

Keywords: Comparison, Finasteride, Fourier Transform-Raman spectroscopy, Lamivudine, Polymorphism

References

1. Melisew TA, Zebasil TM, Ellen M. Advances in surface-enhanced Raman spectroscopy for analysis of pharmaceuticals: A review. Vib Spectrosc 2018;98:50-63.
2. Bathish MA, Gazy AA, Jamal MK. Novel selective spectrophotometric methods for the determination of methimazole in pure form and in pharmaceutical formulation. Int J Pharm Pharm Sci 2020;12:62-9.
3. Bharate SS, Bharate SB, Bajaj AN. Incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: A comprehensive review. J Excip Food Chem 2010;1:3-26.
4. Priya CS. Design and evaluation of Lovastatin solid dispersions incorporated trilayer matrix tablets. Int J Pharm Sci Drug Res 2020;12:368-76.
5. Thenge R, Patel R, Kayande N, Mahajan N. Co-crystals of carvedilol: Preparation, characterization and evaluation. Int J App Pharm 2020;12:42-9.
6. Pindelska E, Sokal A, Kolodziejski W. Pharmaceutical cocrystals, salts and polymorphs: Advanced characterization techniques. Adv Drug Deliv Rev 2017;117:111-46.
7. Bhavana V, Chavan RB, Mannava MK, Nangia A, Shastri NR. Quantification of niclosamide polymorphic forms-a comparative study by Raman, NIR and MIR using chemometric techniques. Talanta 2019;199:679-88.
8. Amado A, Nolasco MM, Ribeiro-Claro PJ. Probing pseudopolymorphic transitions in pharmaceutical solids using Raman spectroscopy: Hydration and dehydration of theophylline. J Pharm Sci 2007;96:1366-79.
9. Suryanarayanan R. Determination of the relative amounts of ?-carbamazepine and ?-carbamazepine in a mixture by powder X-ray diffractometry. Powder Diff 1990;5:155-9.
10. Patel AD, Luner PE, Kemper MS. Quantitative analysis of polymorphs in binary and multi-component powder mixtures by near-infrared reflectance spectroscopy. Int J Pharm 2000;206:63-74.
11. Virtanen T, Maunu SL. Quantitation of a polymorphic mixture of an active pharmaceutical ingredient with solid state 13C CPMAS NMR spectroscopy. Int J Pharm 2010;394:18-25.
12. Mrinalini CD, Pooja BK. Stability indicating HPTLC method for sofosbuvir and velpatasvir in combination. Int J Pharm Sci Drug Res 2020;12:129-35.
13. Khan R, Irchhaiya R. In vitro in vivo evaluation of niosomal formulation of famotidine. Int J Pharm Pharm Sci 2020;12:15-22.
14. Thorat Y, Shegaonkar A, Kumbhar S, Matole V, Hosmani A. Spectrophotometric determination of dasatinib in pharmaceutical formulations. Int J Curr Pharm Res 2020;12:68-71.
15. Rao MC, Reddy RC, Sekhar KB, Reddy YV. FT-Raman spectroscopy with chemometric methods for quantification of lamivudine form II in lamivudine form I. Asian J Chem 2017;29:1735-42.
16. Rao MC, Reddy RC, Sekhar KB, Reddy YV. Identification and detection of finasteride polymorphs in finasteride tablets by FT-Raman spectroscopy. Asian J Chem 2020;32:1865-8.
17. Zivkovic S, Momcilovic M, Staicu A, Mutic J, Trtica M, Savovic J. Spectrochemical analysis of powdered biological samples using transversely excited atmospheric carbon dioxide laser plasma excitation. Spectrochim Acta Part B 2017;128:22-9.
18. Croker DM, Hennigan MC, Maher A, Hu Y, Ryder AG, Hodnett BK. A comparative study of the use of powder X-ray diffraction, Raman and near infrared spectroscopy for quantification of binary polymorphic mixtures of piracetam. J Pharm Biomed Anal 2012;63:80-6.
19. Roberts SN, Williams AC, Grimsey IM, Booth SW. Quantitative analysis of mannitol polymorphs. FT-Raman spectroscopy. J Pharm Biomed Anal 2002;28:1135-47.
20. Dandeu A, Humbert B, Carteret C, Muhr H, Plasari E, Bossoutrot JM. Raman spectroscopy-a powerful tool for the quantitative determination of the composition of polymorph mixtures: Application to CaCO3 polymorph mixtures. Chem Eng Technol 2006;29:221-5.
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RAO M, C. S., C. K. REDDY R, C. SEKHAR KB, and R. R. YV. “DRUG POLYMORPHISM IDENTIFICATION USING FOURIER TRANSFORM-RAMAN SPECTROSCOPY: A COMPARATIVE STUDY OF LAMIVUDINE AND FINASTERIDE DRUGS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 14, no. 1, Jan. 2021, pp. 77-82, doi:10.22159/ajpcr.2021.v14i1.39881.
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