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.