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Stream/Area:
-
Subject:
-
Paper ID:
IJSREM65024
Volume:
10 |
6 |
Jun 2026
Pages:
1-6
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.
Quality Assurance
RBTB
Dept. of Pharmaceutical Sciences,
Rajesh Bhiayya Tope College of Pharmacy, Chh.Sambhajinagar.
Dept. of Pharmaceutical Sciences,
Rajesh Bhiayya Tope College of Pharmacy, Chh.Sambhajinagar.
Dept. of Pharmaceutical Sciences,
Rajesh Bhiayya Tope College of Pharmacy, Chh.Sambhajinagar.
Nafithromycin is India’s first indigenous macrolide antibiotic, which belongs to the sub class of ketolides developed it in India with support from BIRAC. It is a semi synthetic derivative of erythromycin, structurally featuring as tablel auctioneering and a thiadiazole-pyridine side chain, which enhances lung penetration. This innovation marks a milestone in pharmaceutical development and strengthens India’s hand in the global fight against AMR. The drug targets community-acquired bacterial pneumonia (CABP), including drug-resistant infections, and is a major step in combating global antimicrobial resistance (AMR). Nafithromycin shows strong activity against awide range of gram-positive bacteria, including Streptococcus pneumoniae, Streptococcus pyogenes, and atypical pathogens such as Mycoplasma pneumonia.
KEYWORDS
The present thesis was assembled to provide a complete pharmaceutical quality assurance document on analytical method development and validation of nafithromycin by reverse phase HPLC. The front chapters established the therapeutic importance of nafithromycin, the continuing value of RP-HPLC in routine pharmaceutical analysis, and the regulatory framework provided by ICH Q14 and Q2(R2). A detailed literature review then showed that nafithromycin has substantial support in medicinal chemistry, microbiology, pharmacokinetics, and clinical literature, but comparatively fewer open routine assay methods on conventional HPLC systems
1. European Medicines Agency. ICH Q2(R2) validation of analytical procedures: scientific guideline. Amsterdam: EMA; 2026 webpage update. 2. ICH. Q1A(R2) Stability Testing of New Drug Substances and Products. Geneva: ICH; 2003. 3. Kerns EH, Di L. Drug-like Properties: Concepts, Structure Design and Methods. 2nd ed. Oxford: Academic Press; 2016. 4. Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014;4:159-165. 5. Bakshi M, Singh S. Development of validated stability-indicating assay methods—critical review. J Pharm Biomed Anal. 2002;28:1011-1040. 6. Swartz ME, Krull IS. Analytical Method Development and Validation. New York: Marcel Dekker; 2012. 7. Ahuja S, Dong MW. Handbook of Pharmaceutical Analysis by HPLC. Amsterdam: Elsevier; 2005. 8. Snyder LR, Dolan JW. High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model. Hoboken: John Wiley & Sons; 2007. 9. Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. 5th ed. Mumbai: Himalaya Publishing House; 2009. 10. Meyer VR. Practical High-Performance Liquid Chromatography. 5th ed. Chichester: Wiley; 2010.
Publication Date
6/15/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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