• Home
  • Browse Issues
    • In Press
    • Current Issue
    • Special Issue
    • Past Issues
  • About
    • Editorial Board
    • Bibliographic Listings
    • Peer Review Process
    • Open Access Policy
    • Plagiarism Policy
    • Copyright Policy
    • Retraction Policy
    • Editorial Policy
    • Disclaimer
  • Author Guidelines
  • Submit Article
  • Contact

Subscribe to Updates

Get the latest creative news from FooBar about art, design and business.

Facebook Twitter Instagram
International Journal of Pharmaceutical Investigation
Facebook Twitter Instagram
Submit Article Author Guidelines
  • Home
  • Browse Issues
    1. In Press
    2. Current Issue
    3. Special Issue
    4. Past Issues
    5. View All

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023

    A Study of Nitrosamine Impurities and Regulations Governing their Presence in Drug Products

    September 22, 2023

    Phyto-Pharmacological Importance with Nutritional Potential of Eleusine coracana Linn.: A Review

    September 20, 2023

    Type3c Diabetes Mellitus

    September 20, 2023

    A Study on BioBetters: Various Aspects and Regulatory Approval Process

    September 20, 2023
  • About
    • Editorial Board
    • Bibliographic Listings
    • Peer Review Process
    • Open Access Policy
    • Plagiarism Policy
    • Copyright Policy
    • Retraction Policy
    • Editorial Policy
    • Disclaimer
  • Author Guidelines
  • Submit Article
  • Contact
International Journal of Pharmaceutical Investigation
Home»JPHI»Vol 13 Issue 3»Analytical Method Development and Validation of Rivastigmine in its Pure and Pharmaceutical Dosage form Using UPLC
Vol 13 Issue 3

Analytical Method Development and Validation of Rivastigmine in its Pure and Pharmaceutical Dosage form Using UPLC

July 5, 2023Updated:July 7, 20233 Mins Read
Share
Facebook Twitter LinkedIn Pinterest WhatsApp Email

International Journal of Pharmaceutical Investigation, 2023, 13, 3, 595-604.
DOI:10.5530/ijpi.13.3.074
Published: July 2023
Type: Original Article

Authors: 

Aarthi Kommu
Department of Pharmaceutical Quality Assurance, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.

Raja Sundararajan
Department of Pharmaceutical Quality Assurance, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.

ABSTRACT

Objectives: For the quantification of rivastigmine in both its pure form and pharmaceutical formulation, an ultra-performance liquid chromatography method with high speed and sensitivity was created and validated. Materials and Methods: Acquity UPLC BEH C8 (100 mm x 2.1 mm and 1.7 μm) employed to resolve the analysis, and the mobile phase included ammonium phosphate buffer and acetonitrile in a 65:35% v/v ratio. The column temperature was 30°C. The volume of sample injected was 10 μL. The flow rate was 0.5 mL/min, and UV detection was used to detect the analyte at 254 nm. Results: As there was no interferences observed by blank and placebo at the retention time of rivastigmine. According to the results of the degradation investigation, considerable degradation was seen under the conditions of alkali and oxidative stress (peroxide). This led to the conclusion that rivastigmine was susceptible to oxidation and alkali. A study using six replicate injections was carried out to obtain system precision. The predicted % RSD from the rivastigmine peak locations was determined to be 0.2%. The correlation coefficient was determined to be 0.9996, and the suggested UPLC method was linear over the range of 12.5 to 75 g/mL. The accuracy studies were displayed as a % recovery for rivastigmine levels between 50% to 150%. The results obtained were determined to be within the limits, and the maximum percentage of recovery revealed was in between 98 and 102%. As a result, the accuracy of the technique was established. The procedure remains unaffected by variations in column oven temperature and wavelength. All the validation parameters satisfy the ICH Q2 specification acceptance limits, and the technique was validated in accordance with ICH rules. Conclusion: According to ICH criteria, the developed technique was verified for several parameters including accuracy, precision, linearity, specificity, system compatibility, solution stability, and robustness. The results obtained met the requirements for acceptance. It was determined, then, that the proposed UPLC technology was easy to use, precise, and accurate, and that it can be successfully used for the routine analysis of rivastigmine in bulk and pharmaceutical dosage forms.

Keywords: Rivastigmine, UPLC, Method Development, Forced degradation, Validation.

Original Article
Previous ArticleHigh-Cited Papers in Global COVID-19 Vaccine Research
Next Article Validated Reverse-Phase HPLC Method for Quantification of Fluconazole and Quercetin in Pharmaceutical Formulation

Related Posts

Impact of Mobile Radiations on Gliclazide Tablet Formulation

July 21, 2023

Formulation and in vitro Evaluation of pH Dependent Colon Targeted Controlled Release Tablet of Mesalamine Containing Cyamopsis tetragonoloba Gum and Sodium Alginate

July 21, 2023

Formulation, Development and Characterization of Liposome-based Gel of Eberconazole Nitrate for Topical Delivery

July 21, 2023
Download PDF
Cite this Article
Citation Output

Read in Readcube
  • Download PDF
  • ReadCube
Citations & Metrics
Article Metrics
  • Dimensions Metrics
  • Page Views
  • Related
Total Views 0
Last Month Views 0
Click for PLUM.MX Metrics Search this article in Google Scholar Related Articles in Google Scholar Search related in PUBMED


About
About

publishing peer-reviewed scholarly reviews, themed issues and research articles within the entire scope of the Pharmaceutical field. The journal particularly aims to foster the dissemination of scientific information by publishing manuscripts related to Pharmacy and Related Fields.

We're accepting new submissions right now.

Facebook Twitter RSS
Editor Picks

Overview on Evolving Variants of Novel Coronavirus and Control Measures in India

July 5, 2023

An Overview of the Various Appropriate Types of Cell Lines for the Production of Monoclonal Antibodies

July 5, 2023

Ashwagandha: A Flagship Herb of Ayurveda from Past to Present Nano Era

July 5, 2023

Dental Pulp Stem Cells: Biology and Promise for Regenerative Medicine

July 5, 2023
STAY CONNECTED

Contact Editor-In-Chief
Editor, International Journal of Pharm Investigation
#9, Vinnse Tower, Wheeler Road Extn.
St. Thomas Town, 560084, Bangalore, INDIA
Email: editor@jpionline.org

© 2023 Phcog.Net | Published by : EManuscript.
  • Home
  • Submit Article
  • Disclaimer
  • Contact

Type above and press Enter to search. Press Esc to cancel.