Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 6 Issue 12

Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Serdexmethylphenidate and Dexmethylphenidate in Bulk and Formulation

Dasari Vasavi Devi*, S Siva Jyothi, S Srinithya, S Shanawaz, S Nelson Kumar and M Pravallika

Department of Pharmaceutical Analysis, P. Rami reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, India

*Corresponding Author: Dasari Vasavi Devi, Department of Pharmaceutical Analysis, P. Rami reddy Memorial College of Pharmacy, Kadapa, Andhra Pradesh, India.

Received: October 25, 2022; Published: November 30, 2022

Abstract

The objective of this study was to develop and validate the stability-indicating method for the simultaneous estimation of the Serdexmethylphenidate and Dexmethylphenidate in capsule dosage form. Chromatogram was gone through Std Discovery C8 (150 x 4.6 mm, 5µ) Mobile phase prepared with Buffer 0.01N KH2PO4:Acetonitrile taken in the proportion 60:40 was siphoed through column with flow of 1ml/min. Buffer utilized in this strategy was potassium dihydrogen ortho phosphate buffer. Temperature was kept up with 30°C. Optimized wavelength chose was 260 nm. Retention time of Serdexmethylphenidate and Dexmethylphenidate were viewed as 2.555 min and 3.207 min. %RSD of the Serdexmethylphenidate and Dexmethylphenidate were and found to be 1.3 and 1.3 respectively. Serdexmethylphenidate and Dexmethylphenidate got the 99.93% and 99.93% recovery. From the regression equations the LOD, LOQ values calculated, for Serdexmethylphenidate 0.25 µg/ml, 0.76 µg/ml and Dexmethylphenidate 0.04 µg/ml, 0.11 µg/ml respectively. Regression equation of Serdexmethylphenidate is y = 47119x + 4918, and y = 67584x + 1883 of Dexmethylphenidate. As the Retention time and run time decreased which shows the developed method was simple and economic.

Keywords: RP-HPLC; Serdexmethylphenidate; Dexmethylphenidate

References

  1. Thapar A and Cooper M. “Attention deficit hyperactivity disorder”. Lancet 10024 (2016): 1240-1250.
  2. Childress AC., et al. “An update on the pharmacokinetic considerations in the treatment of ADHD with long-acting methylphenidate and amphetamine formulations”. Expert Opinion on Drug Metabolism and Toxicology 11 (2019): 937-974.
  3. FDA Approved Drug Products: AZSTARYS (serdexmethylphenidate and dexmethylphenidate) capsules.
  4. Faraone SV. “The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatriccomorbidities”. Neuroscience and Biobehavioral Reviews 87 (2018): 255-270.
  5. KemPharm Poster: Braeckman., et al. American Professional Society for ADHD and Related Disorders, (2018).
  6. Liu F., et al. “Dexmethylphenidate hydrochloride in the treatment of attention deficit hyperactivity disorder”. Neuropsychiatric Disease and Treatment 4 (2006): 467-73.
  7. Tremblay S., et al. “The Effects of Methylphenidate (Ritalin) on the Neurophysiology of the Monkey Caudal Prefrontal Cortex”. eNeuro1 (2019).
  8. Kimko HC., et al. “Pharmacokinetics and clinical effectiveness of methylphenidate”. Clinical Pharmacokinetics 6 (1999): 457-470.
  9. Sunil Rayudu M., et al. “Analytical method development and validation of Dexmethylphenidate and Serdexmethylphenidate by using RP-HPLC in bulk and pharmaceutical dosage form”. International Journal of Applied Pharmaceutics 2 (2022): 110-115.
  10. Veena Boda and Ajitha Makula. “A validated stability indicating RP-HPLC method development and validation for simultaneous estimation of serdexmethylphenidate and dexmethylphenidate inpharmaceutical dosage form”. World Journal of Pharmaceutical Sciences 10 (2022): 30-37.
  11. Akshay Namdevrao Londhe and T M Kalyankar. “Method development and validation for simultaneous estimation of Serdexmethylphenidate and Dexmethylphenidate in synthetic mixture by using RP-HPLC”. World Journal of Pharmacy and Pharmaceutical Sciences4 (2022): 1719-1729.
  12. Gaddey Pridhvi Krishna and Raja Sundararajan. “Development and validation of stability indicating UPLC method for the simultaneous estimation of Serdexmethylphenidate and Dexmethylphenidate in bulk and theircombined dosage form”. 21.5 (2022): 80-97.
  13. Dasari Vasavi Devi and Shaik Umme Salma. “Simultaneous Estimation of Ceritinib and Lenvatinib Using RP-HPLC Method". Acta Scientific Pharmaceutical Sciences4 (2022): 02-07.
  14. International Conference on the Harmonisation, ICH Harmonized Tripartite Guideline. Stability Testing of New Drug Substances and Products Q1A (R2). (2003).
  15. International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1), November (2005).

Citation

Citation: Dasari Vasavi Devi., et al. “Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Serdexmethylphenidate and Dexmethylphenidate in Bulk and Formulation". Acta Scientific Pharmaceutical Sciences 6.12 (2022): 60-67.

Copyright

Copyright: © 2022 Dasari Vasavi Devi., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




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