Author(s):
Ghogare Jyoti D., Panchal Pranita P., Rathod Sayali P., Jadhao U. T.
Email(s):
jyotighogare8275@gmail.com
DOI:
10.52711/2231-5675.2023.00004 
Address:
Ghogare Jyoti D.*, Panchal Pranita P., Rathod Sayali P., Jadhao U. T.
Department of Pharmaceutical Quality Assurance, SVP College of Pharmacy (B. Pharmacy), Hatta Tq. Basmat, Dist - Hingoli.
*Corresponding Author
Published In:
Volume - 13,
Issue - 1,
Year - 2023
ABSTRACT:
Chromatography is non-destructive procedure for resolving a multi-component mixture of solids, gases, Liquids. HPTLC is use of validated methods for qualitative and quantitative analysis. HPTLC is playing an important role in analytical world and a complementary method for HPLC. The analytical method was evaluated by using parameters such as Linearity, Precision, Accuracy, Limit of detection and Limit of quantification, Specificity, Robustness. In this method 100ng µL-1 and 750ng µL-1 volume of standard stock solutions of Nortriptyline and Pregabalin were taken, respectively. The mobile phase contains Toluene: Ethyl acetate: Methanol (6: 2: 1, v/v/v). Standard stock solutions were applied by over spotting on HPTLC plate with the help of CAMAG 100µl sample syringe, Linomat 5 sample applicator. The development chamber was saturated for 15 min. The plate was scanned at 210nm. The retention factors of PREGA and NORT were found to be PREGA: 0.48±0.03, NORT: 0.70±0.07. The % drug content (mean±S.D.) were found to be 99.32±1.39 for NORT and 99.75±1.15 for PREGA. The results of stress degradation studies revealed that NORT was prone to hydrolysis, oxidative, thermal and photolytic degradation whereas PREGA was found susceptible to hydrolysis, oxidative, thermal degradation but stable under photolytic stress conditions.
Cite this article:
Ghogare Jyoti D., Panchal Pranita P., Rathod Sayali P., Jadhao U. T. Stability Indicating HPTLC Method Development and Validation for Estimation of Nortriptyline and Pregabalin in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(1):21-9. doi: 10.52711/2231-5675.2023.00004
Cite(Electronic):
Ghogare Jyoti D., Panchal Pranita P., Rathod Sayali P., Jadhao U. T. Stability Indicating HPTLC Method Development and Validation for Estimation of Nortriptyline and Pregabalin in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(1):21-9. doi: 10.52711/2231-5675.2023.00004 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-1-4
REFERENCES:
1. htpp://pubchem.ncbi.nlm.nih.gov/compound/pregabalin
2. htpp://pubchem.ncbi.nlm.nih.gov/compound/nortriptyline
3. A. Hala, G.L. Seth., S. D. Bihani, “HPTLC Instrumentation: An Overview”, Article at Pharmatutor.
4. H. C. Andola, V. K. Purohit, High Performance Thin Layer Chromatography (HPTLC): A Modern Analytical tool for Biological Analysis, Nature and Science, 2010, volume 8, 58-61.
5. S. T. Thoke, U. T. Jadhao, G.N. Dhembre , Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Dolutegravir Sodium and Rilpivirine Hydrochloride in Pure Bulk Form, Asian Journal of Pharmaceutical Analysis 2022,12(3),1-6,
6. G. Lavanya, M. Sunil, M.M. Eswarudu, M. Chinna Eswaraiah, K. Harisudha and B. Naga Spandana, “Analytical Method Validation: An Updated Review”, International Journal of Pharmaceutical Sciences and Research, 2013, volume 4, 1280-1286.
7. O. Mcpolin, “Validation of Analytical methods for Pharmaceutical Analysis”, Mourne Training Service, 2009, 1-152.
8. M. Blessy, R. Patel, N. Prajesh. Prajapati, Y.K. Agrawal, “Development of forced degradation and stability indicating studies of drugs-A review”, Journal of Pharmaceutical Analysis 2014, Volume 4, 159-165.
9. S.S. Quadri, L.V. Sonwane, B. N. Poul, S.N. Kamshette, “Review on Stability Indicating Assay Methods” (SIAMs), Pharmatutor Pharmacy Infopedia, 2014, volume 2, 16-31.
10. N. Mewada, B. Patel, J. Patel, K. Vegad, V. Patel, “Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Pregabalin and Nortriptyline in Tablet”, International Journal for Pharmaceutical Research Scholars, 2017, volume 2, 1-7.
11. V. Singh, R. K. Singh, R. K. Gupta, S. R. Swain, J. Sahoo, “Development and validation of RP-HPLC method for the assay of pregabalin capsule”, World Journal of Pharmacy and Pharmaceutical Sciences, 2013, volume 3, 703-711.
12. J. A. Mohan, B. Rajkumar, T. Bhavya, A. Ashok Kumar, “RP-HPLC method development and validation for the simultaneous quantitative estimation of pregabalin, mecobalamin and alpha lipoic acid in capsules”, International Journal of Pharmacy and Pharmaceutical Sciences, 2014, volume 6, 270-277.
13. M. NaveenKumar, D. SaiMalakondaiah, G. U. Sree, A. Ajitha, V. U. Maheshwara Rao, “Development and validation of stability indicating RP-HPLC method for simultaneous determination of gabapentin and nortriptyline in pharmaceutical dosage form”, International Journal of Pharmaceutical Research & Analysis, 2015, volume 5, 13-17.
14. A. Tripathi, R.P.S Rathor, P.R. Kamble, G. Vyas, “RP-HPLC Method for Estimation of Acelofenac and Pregabalin in Combined Dosage Form”, International Journal of Pharmamedix India, 2014, volume 2, 764-780.
15. K. K. Bhatt, E. M. Patelia and A. Mori, “Simultaneous Estimation of Pregabalin and Methylcobalamine in Pharmaceutical Formulation by RP-HPLC Method”, Journal of Analytical and Bioanalytical Techniques, 2013, volume 4, 159.
16. P. Vukkum, J. Moses Babu and R. Muralikrishna, “Stress degradation behavior of pregabalin, identification of degradation impurities and development of stability indicating UPLC method”, International Journal of Pharmaceutical Sciences and Research, 2015, volume 6, 2241-2257.
17. A. J. Patel, H. Kadikar, “Stability Indicating HPLC Method for Simultaneous Estimation of Pregabalin and Methylcobalamin from Combined Dosage Form”, Journal of Pharmaceutical Science and Bioscientific Research, 2017, volume 7, 111-177.
18. ICH, Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, IFPMA, Geneva, Nov 2003, 1-22.