Authors :
A.Raja Reddy; L. Noel Shepherd
Volume/Issue :
Volume 9 - 2024, Issue 9 - September
Google Scholar :
https://tinyurl.com/umca3nw2
Scribd :
https://tinyurl.com/4bd2szw8
DOI :
https://doi.org/10.38124/ijisrt/IJISRT24SEP708
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Abstract :
An ADHD medication called Azstarys was
approved by the FDA in March 2021.Because it
combined serdexmethylphenidate and
dexmethylphenidate for the first time, it is unique.
Treatment for Attention Deficit Hyperactivity Disorder
(ADHD) begins with a prodrug called
serdexmethylphenidate. CNS stimulants include
serdexmethylphenidate. People six years of age and older
with attention deficit hyperactivity disorder (ADHD) are
taken serdexmethylphenidate, a prodrug of
dexmethylphenidate, in addition to dexmethylphenidate.
Serdexmethylphenidate is a prodrug of the central
nervous system stimulant dexmethylphenidate. It alters
neurotransmission in the central nervous system by
increasing extracellular dopamine and norepinephrine
numbers.3[11] As a central nervous system stimulant,
serdexmethylphenidate carries a risk of usage, addiction,
and abuse that should be monitored. In addition,
patients need to be assessed. The accuracy, precision,
linearity, robustness, limits of detection and quantitation,
system adaptability, robustness, and other factors can all
be used to validate the RP-HPLC technology.
Keywords :
Dexmethylphenidate, Serdexmethylphenidate, RP-HPLC, Development, Validation.
References :
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- Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Arlington: American Psychiatric Publishing. 2013. pp. 59–65.
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Washington, D.C.: American Psychiatric Publishing. February 2022. ISBN 978-0-89042-575-6. OCLC 1288423302.
- Brown TE (October 2008). “ADD/ADHD and Impaired Executive Function in Clinical Practice”. Current Psychiatry Reports. 10(5):407-411.
- Dexmethylphenidate Hydrochloride Monograph for Professionals Drugs.com. American Society of Health System pharmacists. Retrieved 15 April 2019.
- Bansal V, Pal O. P and Sharma P. K. A Review of High-Performance Liquid Chromatography. Journal of Global Pharma technology (2010).
- B.K Sharma, Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23rd Edition Goel publication, Meerut, (2007)
- Dr. S. Ravi Shankar, Text book of Pharmaceutical Analysis, Fourth Edition, Pg 13.1-13.2.
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- Subrahmanyam Talari, V. Anuradha et al.., A Newly Developed Reverse Phase-High Performance Liquid Chromatography Method for the Assay of Dexmethylphenidate and Serdexmethylphenidate with PDA, Journal of Pharmaceutical Research International, 2021; 33(31B): 203-21
- Harmonised tripartite guideline ich validation of analytical procedures: text and methodology q2(r1) current step 4 version, November, 2005.
- Liu F, Minami H and Silva RR. Dexmethylphenidate hydrochloride in the treatment of attention deficit hyperactivity disorder. Neuropsychiatric Disease and Treatment. 2006;2(4):467-473
- Londhe AN and Kalyankar TM. Method development and validation for simultaneous estimation of Serdexmethylphenidate and Dexmethylphenidate in synthetic mixture by using RP-HPLC. World Journal of Pharmacy and Pharmaceutical Sciences. 2022;11(4):1719-1729.
- International Conference on Harmonization (ICH) guidelines. Stability testing on new drug substances and products” (ICH (2003) Stability Testing of New Drug Substances and Products, Q1AR2, International Conference on Harmonization, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland
- Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Pharm Tech Online. 2000; 24:1–14
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- . Gunn BG, Baram TZ. Stress and seizures: space, time and hippocampal circuits. Trends Neurosci. 2017;40(11):667-79. doi: 10.1016/j.tins.2017.08.004, PMID 28916130
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- de Cock M, Maas YG, van de Bor M. Does perinatal exposure to endocrine disruptors induce autism spectrum and attention deficit hyperactivity disorders? review. Acta Paediatr. 2012;101(8):811-8. doi: 10.1111/j.1651- 2227.2012.02693.x, PMID 22458970.
- . Charu Pandya P, Sadhana Rajput J. Development and validation of stability-indicating method RP-HPLC method of acotiamide. Int J Pharm Pharm Sci. 2018; 10:1-8.
An ADHD medication called Azstarys was
approved by the FDA in March 2021.Because it
combined serdexmethylphenidate and
dexmethylphenidate for the first time, it is unique.
Treatment for Attention Deficit Hyperactivity Disorder
(ADHD) begins with a prodrug called
serdexmethylphenidate. CNS stimulants include
serdexmethylphenidate. People six years of age and older
with attention deficit hyperactivity disorder (ADHD) are
taken serdexmethylphenidate, a prodrug of
dexmethylphenidate, in addition to dexmethylphenidate.
Serdexmethylphenidate is a prodrug of the central
nervous system stimulant dexmethylphenidate. It alters
neurotransmission in the central nervous system by
increasing extracellular dopamine and norepinephrine
numbers.3[11] As a central nervous system stimulant,
serdexmethylphenidate carries a risk of usage, addiction,
and abuse that should be monitored. In addition,
patients need to be assessed. The accuracy, precision,
linearity, robustness, limits of detection and quantitation,
system adaptability, robustness, and other factors can all
be used to validate the RP-HPLC technology.
Keywords :
Dexmethylphenidate, Serdexmethylphenidate, RP-HPLC, Development, Validation.