Recent issues of bio analytical sample processing technique in pharmaceuticals

Govinda Rao Yedlapalli; Sujatha  Gudumuru; Kambagiri Swamy Buragala

Govinda Rao Yedlapalli Department of Pharmaceutical Analysis & Quality Assurance, Viswa Bharathi College of Pharmaceutical Sciences, Perecherla, NRT Road, Medikonduru (M), Guntur – 522109, Guntur (Dist), Andhra Pradesh, India.
Sujatha Gudumuru Krishna Teja Pharmacy College, Chadalawada Nagar, Reniguntla Road, Tirupathi-517506, Andhra Pradesh, India.
Buragala Kambagiri Swamy Aurobindo Pharma Limited, Palepolam, Naidupeta-524421, Andhra Pradesh, India

Abstract

Sample processing is taken into account as that of the bottle - neck step such as bio analysis it because every biomedical composite has its very own different problems but instead complexity. Qualified preconcentration to derive the specified sample components and take away duplicative sub - assemblies is a vital process at every bio analytical approach. Now that it is commonly recognized such a bio analysis is really an inherent element of such pharmacokinetic/pharmacodynamic characterization of either a novel chemical organization as from moments among its breakthrough as well as during different phases anyway drug discovery, resulting in the it’s marketing authorizations. Conventional liquid–liquid extraction (LLE), protein precipitation (PP) or solid-phase extraction (SPE) strategies now are spent so long regarded as methodologies of such previous. A last decade must have witnessed a significant discovery and development of new sample pre treatment out bio analysis. Advances throughout SPE methods also including selective means to that end as well as in the overall strategy to SPE, also including fusion substance or molecularly imprinted polymer SPE, have indeed been addressed. Regulation guidelines and standards can be found from it and participation of multiple approved public entities. Microbiological concept screening but also affirmation can just be conducted to diverse range verification metrics using LC-MS/MS and many other analysis techniques. Also, there are diverse range stability procedures have been collection that are beneficial such as bio analysis. Regulation guidelines but instead standards can indeed be discovered from that and inclusion anyway multiple accepted public entities. Microbiological concept development but is also confirmation can be undertaken complete wide selection checking performance indicators to use LC-MS/MS and most other critical to inform. Also, there are wide selection reliability processes have now been gathering that have been useful also including bio analysis.

Keywords: Solid Phase Extraction, protein precipitation, Bioanalytical Sample, Pharmaceuticals

References

1. C. Bylda, r. Thiele, u. Kobold, et al., recent advances in sample preparation techniques to overcome difficulties encountered during quantitative analysis of small molecules from bio fluids using lc-ms/ms. Analyst. 139: 2265-2276, 2014.
2. Humphrey mj. Application of metabolism and pharmacokinetic studies to the drug discovery process. Drug metabolism reviews. 28: 473-89,1996.
3. Singh, a., srinivasan, a.k., chakrapani, l.n. and kalaiselvi, p., 2019. Lox-1, the common therapeutic target in hypercholesterolemia: a new perspective of antiatherosclerotic action of aegeline. Oxidative medicine and cellular longevity, 2019.
4. Uppugalla s, male u, srinivasan p. Design and synthesis of heteroatoms doped carbon/polyaniline hybrid material for high performance electrode in supercapacitor application. Electrochimica acta. 2014 nov 10;146:242-8.
5. Saunders kc, ghanem a, boon hon w, hilder ef and haddad pr. Separation and sample pre-treatment in bioanalysis using monolithic phases: a review. Analytica chimica acta. 652(1–2): 22–31, 2009.
6. Singh, a., gowtham, s., chakrapani, l.n., ashokkumar, s., kumar, s.k., prema, v., bhavani, r.d., mohan, t. And sathyamoorthy, y.k., 2018. Aegeline vs statin in the treatment of hypercholesterolemia: a comprehensive study in rat model of liver steatosis. Functional foods in health and disease, 8(1), pp.1-16.
7. Ludwing h. Validaton of analytical methods. Agilent technologies. 1-65, 2010.
8. Male u, uppugalla s, srinivasan p. Effect of reduced graphene oxide–silica composite in polyaniline: electrode material for high-performance supercapacitor. Journal of solid state electrochemistry. 2015 nov;19(11):3381-8.
9. Singh, a., kumar, a. And kalaiselvi, p., 2018. Aegeline, targets lox1, the receptor for oxidized ldl to mitigate hypercholesterolemia: a new perspective in its anti-atherosclerotic action. Free radical biology and medicine, 128, p.s41.
10. Abhilasha, s., narasimhan, c.l., kumar, s.a., kumar, s.n.k., bhavani, r.d., thangarajeswari, m., prema, v. And kalaiselvi, p., 2017. Ethanolic extract of aegle marmelos mediates its hypocholesterolemic effect by retarding circulatory oxidized ldl formation via 12/15 lipoxygenase pathway.
11. Uppugalla s, srinivasan p. High-performance supercapacitor coin cell: polyaniline and nitrogen, sulfur-doped activated carbon electrodes in aqueous electrolyte. Journal of solid state electrochemistry. 2019 jan;23(1):295-306
12. Zhang j, wu h, kim e and el-shourbagy ta. Salting-out assisted liquid/ liquid extraction with acetonitrile: a new high throughput sample preparation technique for good laboratory practice bioanalysis using liquid chromatography–mass spectrometry. Biomedical chromatography.23(4): 419–425, 2009.
13. Uppugalla s, srinivasan p. Polyaniline nanofibers and porous ni [oh] 2 sheets coated carbon fabric for high performance super capacitor. Journal of applied polymer science. 2019 nov 5;136(41):48042.
14. Singh, a., 2022. Role of microbial metabolites in cardiovascular and human health. In microbiome, immunity, digestive health and nutrition (pp. 137-148). Academic press.englard s and seifter s. Precipitation techniques. Methods in enzymology.182: 285–300, 1990.
15. Uppugalla s, boddula r, srinivasan p. Methyl triphenylphosphonium permanganate as a novel oxidant for aniline to polyaniline-manganese (ii, iv) oxide: material for high performance pseudocapacitor. Journal of solid state electrochemistry. 2018 feb;22(2):407-15.
16. Ferrer i and barcelo d. N of new solid-phase extraction materials for the selective enrichment of organic contaminants from environmental samples. Trends in analytical chemistry.18(3): 180–192, 1999.
17. Rahul g. Ingle, su zeng, huidi jiang, wei-jie fang. Current developments of bioanalytical sample preparation techniques in pharmaceuticals. Journal of pharmaceutical analysis. 12 : 517-529, 2022.
18. Singh, a., 2022. Role of microbial metabolites in cardiovascular and human health. In microbiome, immunity, digestive health and nutrition (pp. 137-148). Academic press.
19. Tiwari g. Tiwari r. Bioanalytical method validation: an updated review. Pharmaceutical methods. 1: 25- 38, 2010.
20. Boini, K.M., singh, A. and Koka, S.S., 2021. Gut Microbial Metabolite Trimethylamine N-oxide Enhances Endoplasmic Reticular Stress and Promotes Endothelial Dysfunction. Circulation, 144(Suppl_1), pp.A14071-A14071.
21. Shiv chandra singh, a., yu, a., chang, b., li, h., rosenzweig, a. And roh, j.d., 2021. Exercise training attenuates activin type ii receptor signaling in the aged heart. Circulation, 144(suppl_1), pp.a14259-a14259.
22. Roh, j., hill, j.a., singh, a., valero-muñoz, m. And sam, f., 2022. Heart failure with preserved ejection fraction: heterogeneous syndrome, diverse preclinical models. Circulation research, 130(12), pp.1906-1925.
23. Blume h, bolton e, brudny-kloppel m, grebe s, lausecker b, et a, work shop/conference report on ema draft guidelines on validation of bioanalytical methods. European journal of pharmaceutical sciences. 42:300-305, 2011.