Author(s):
Arun Maruti Kashid, Shivanjali Balasaheb Sable, Amey Chandrakant Khilare, Aditya Mahesh Shinde
Email(s):
arunkashid2006@gmail.com
DOI:
10.52711/2231-5675.2025.00026 
Address:
Arun Maruti Kashid*, Shivanjali Balasaheb Sable, Amey Chandrakant Khilare, Aditya Mahesh Shinde
Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India 411041.
Department of Pharmaceutical Quality Assurance, Sinhgad Technical Education Society’s Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India 411041.
*Corresponding Author
Published In:
Volume - 15,
Issue - 3,
Year - 2024
ABSTRACT:
The simple, accurate, precise and sensitive High Performance Thin Layer Chromatography (HPTLC) method was developed and validated. The stationary phase used was precoated Silica gel F254 plates. The mobile phase used for method development contains methanol: ethyl acetate: ammonia (6: 4: 0.2 v/v). From the overlain spectra of standard and tablet the detection wavelength of 245 nm was selected. The validation parameters like linearity, precision, accuracy, limit of detection, limit of quantification and robustness were performed. For the linearity concentration range selected was 100-500 ng/band. The coefficient of regression (R2) was found to be 0.9900. The percent Relative Standard Deviation (%RSD) for intraday and interday precision study was found to be 0.3301-1.9046%. The % recovery was performed to study accuracy and the results were found to be 98.70-100%. The limit of detection and limit of quantitation was found to be 527.04 and 1597.45 ng/band. The robustness of the method was studied by making deliberate changes in the mobile phase composition and saturation time, the %RSD was found to be 0.9137 and 1.0869. The forced degradation study was performed in acidic, basic, oxidative and neutral conditions. The degradants were observed. The method was validated as per ICH guidelines and developed method can be used for routine analysis in quality control laboratories.
Cite this article:
Arun Maruti Kashid, Shivanjali Balasaheb Sable, Amey Chandrakant Khilare, Aditya Mahesh Shinde. HPTLC Method Development and Validation for Nortriptyline Hydrochloride in Bulk and it’s Tablet. Asian Journal of Pharmaceutical Analysis. 2025; 15(3):170-4. doi: 10.52711/2231-5675.2025.00026
Cite(Electronic):
Arun Maruti Kashid, Shivanjali Balasaheb Sable, Amey Chandrakant Khilare, Aditya Mahesh Shinde. HPTLC Method Development and Validation for Nortriptyline Hydrochloride in Bulk and it’s Tablet. Asian Journal of Pharmaceutical Analysis. 2025; 15(3):170-4. doi: 10.52711/2231-5675.2025.00026 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-15-3-2
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