Journals Information
Advances in Pharmacology and Pharmacy Vol. 13(4), pp. 639 - 651
DOI: 10.13189/app.2025.130414
Reprint (PDF) (1962Kb)
Development and Validation of QbD Driven Stability Indicating UV Spectrophotometric Method for Simultaneous Estimation of Trigonelline and Piperine and its Application to Nanoformulation
Akshay K Patil *, Adarsh C Umarani , Sushant Madar , Srushti Murgod , Simran Gawas
Department of Pharmacognosy, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India
ABSTRACT
The objective of current research work was to develop quality by design based simple stability indicating UV Spectrophotometric method for simultaneous analysis of trigonelline and piperine and its application to prepared nanoformulation. A simple, cost economic method was developed and validated as per ICH guidelines. Design of experiment was used to optimize the method where sonication time and scanning interval were identified as independent variables and absorbance was considered as a dependent variable. A simple 32 full factorial design with 9 runs was used to optimize the method. Water is used as a major solvent. The optimized run (10 min sonication time and medium scanning interval) was extensively validated as per ICH guidelines. A forced degradation study was also carried out. Furthermore, the devised method was successfully applied for the estimation of drugs in prepared nanoformulation. Based on the result, the method was found to be simple, accurate, precise, and robust as evidenced by validation parameters which all fall within acceptance limits. A linear relationship was determined between the concentration ranging from 2 to 10 /ml, with a regression coefficient of 0.999 for trigonelline (265nm) and piperine (342nm). Both precision assays showed a percent RSD of less than 2 indicating the precise nature of the method. The percentage recovery ranged from 99.54 to 101.43 % for trigonelline and 99.88 to 101.83 % for piperine, indicating promising accuracy. Trigonelline showed LOD and LOQ values of 1.064 /mL and 3.22 /mL and piperine showed 0.814 /mL and 2.46 /mL respectively which proves the sensitive nature of the method. Percent RSD less than 2 indicates that the developed method is rugged and robust. Further, acidic, basic and oxidative degradation was in the range of 10- 19% whereas photolytic assay showed pronounced degradation characteristics (44-52%). Additionally, the developed method was successfully utilized for the estimation of trigonelline and piperine in prepared nanoformulations. Therefore, it can be inferred that the current study will serve as a foundation for the quality assessment of trigonelline and piperine naanoformulation utilizing the Quality by Design approach.
KEYWORDS
Quality by Design, Trigonelline, Piperine, UV Spectroscopic, Validation
Cite This Paper in IEEE or APA Citation Styles
(a). IEEE Format:
[1] Akshay K Patil , Adarsh C Umarani , Sushant Madar , Srushti Murgod , Simran Gawas , "Development and Validation of QbD Driven Stability Indicating UV Spectrophotometric Method for Simultaneous Estimation of Trigonelline and Piperine and its Application to Nanoformulation," Advances in Pharmacology and Pharmacy, Vol. 13, No. 4, pp. 639 - 651, 2025. DOI: 10.13189/app.2025.130414.
(b). APA Format:
Akshay K Patil , Adarsh C Umarani , Sushant Madar , Srushti Murgod , Simran Gawas (2025). Development and Validation of QbD Driven Stability Indicating UV Spectrophotometric Method for Simultaneous Estimation of Trigonelline and Piperine and its Application to Nanoformulation. Advances in Pharmacology and Pharmacy, 13(4), 639 - 651. DOI: 10.13189/app.2025.130414.