Author(s):
Prajakta H Patil, B. M. Gurupadayya, P. D. Hamrapurkar
Email(s):
pdhamrapurkar13@gmail.com
DOI:
10.5958/0974-360X.2020.00464.3 
Address:
Prajakta H Patil1, B. M. Gurupadayya2, P. D. Hamrapurkar*
1Department of Pharmaceutical Analysis, Principal K.M Kundanani College of Pharmacy, Colaba, Mumbai-400005, Maharashtra.
2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore-570015, Karnataka.
*Corresponding Author
Published In:
Volume - 13,
Issue - 6,
Year - 2020
ABSTRACT:
Objectives: Tadalafil Hydrochloride is a selective phosphodiesterase type 5- inhibitor. A selective, sensitive and precise stability indicating high-performance thin layer chromatography (HPTLC) method was successfully developed for quantitative estimation of tadalafil Hydrochloride in bulk drug and tablet formulation in presence of its degradation products. Methods: Tadalafil and its degradation products were separated by using pre-coated silica gel 60F-254 aluminum plates as stationary plate and with hexane: isopropyl alcohol: acetonitrile (5:4:1 v/v/v) mobile phase. Densitometry scanning of tadalafil Hydrochloride was done by using CAMAG TLC scanner III at 285nm. The RF value of tadalafil Hydrochloride was found to be 0.65 with optimized method parameters. Results: The developed method was validated in terms of linearity (200-600ng/spot), precision (inter-day variation, 0.70 to 2.4% and intra-day variation, 0.069 to 0.026%), accuracy (101.3±0.50) and specificity. The limit of detection (LOD) and limit of quantitation (LOQ) were 30ng and 90ng per spot respectively. Tadalafil Hydrochloride was exposed to force degradation by acid and alkali hydrolysis, oxidation, photo degradation and thermal degradation. The drug was found to be susceptible to acid and base hydrolysis and oxidation. The validated method was successfully applied for the separation of tadalafil Hydrochloride and its degradation products. All the peaks of degraded products were resolved from the tadalafil Hydrochloride with significantly different Rf values. Conclusion: As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.
Cite this article:
Prajakta H Patil, B. M. Gurupadayya, P. D. Hamrapurkar. Stability Indicating HPTLC Determination of Tadalafil Hydrochloride in Bulk Drug and Pharmaceutical Formulations. Research J. Pharm. and Tech 2020; 13(6):2608-2614. doi: 10.5958/0974-360X.2020.00464.3
Cite(Electronic):
Prajakta H Patil, B. M. Gurupadayya, P. D. Hamrapurkar. Stability Indicating HPTLC Determination of Tadalafil Hydrochloride in Bulk Drug and Pharmaceutical Formulations. Research J. Pharm. and Tech 2020; 13(6):2608-2614. doi: 10.5958/0974-360X.2020.00464.3 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-6-14
REFERENCES:
1. Nikolaou P, Papoutsis I, Athanaselis S, Alevisopoulos G, Khraiwesh A, Pistos C, Spiliopoulou C. Development and validation of a GC/MS method for the determination of tadalafil in whole blood. J Pharm Biomed Anal 2011 Nov 1;56(3):577-81.
2. Sutar AS, Magdum CS, Patil SS, Naikawadi NS. RP-HPLC estimation of tadalafil in tablet dosage form. Int J Chem Sci 2008; 6(2):1223-7.
3. Dinger J, Meyer MR, Maurer HH. Development and validation of a liquid-chromatography high-resolution tandem mass spectrometry approach for quantification of nine cytochrome P450 (CYP) model substrate metabolites in an in vitro CYP inhibition cocktail. Anal Bioanal Chem 2014; 406(18):4453-64.
4. Giri AD, Bhusari VK, Dhaneshwar SR. Validated HPLC method for simultaneous quantitation of tadalafil and dapoxetine Hydrochloride in bulk drug and formulation. Int J Pharm Pharm Sci 2012; 4(2):654-58.
5. Patel JK, Patel NK. Stability-indicating RP-HPLC method for the determination of ambrisentan and tadalafil in pharmaceutical dosage form. Sci Pharm 2014; 82(4):749-63.
6. Reddy BP, Reddy KA, Reddy MS. Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations. Res Pharm Biotech, 2010; 2:1–6.
7. Aboul-Enein HY, Ali I., Determination of tadalafil in pharmaceutical preparation by HPLC using monolithic silica column. Talanta, 2005; 65:276–80.
8. Ali I, Aboul-Enein H.Y, Validated method for tadalafil analysis in pharmaceutical preparations by capillary electrophoresis. Chromatographia 2004; 60(3–4):187–91.
9. Patel SA, Patel NJ. High performance thin layer chromatographic method for determination of Tadalafil in tablet dosage form.American J PharmTech Res 2011; 1(3):138-146.
10. Thoppil SO, Cardoza RM, Amin PD. Stability indicating HPTLC determination of trimetazidine as bulk drug and in pharmaceutical formulations. J Pharm Biomed Anal 2001; 25(1):15-20.
11. Ahuja S, Scypinski S, editors. Handbook of modern pharmaceutical analysis. Academic press; 2001 Aug 9.
12. Sweetman SC. 34th ed. London: Pharmaceutical Press; 2007. Martindale: The Complete Drug Reference; p. 875
13. Kshirsagar VB, Deokate UA, Bharkad VB, Khadabadi SS. HPTLC method development and validation for the simultaneous estimation of diosgenin and levodopa in marketed formulation. Asian J Res Chem. 2008 Jul;1(1):36-9.
14. Dedania Z, Dedania R, Vidhyasagar G, Patel B, Ramolia C, Karkhanis V. Development and Validation of HPTLC Method for Simultaneous Estimation of Omeprazole and Ondansetron in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2009;2(4):574-000.
15. Kalaiselvi P, Amirtharaj RV, Venkatachalam T, Kumar NS. HPTLC Method for Simultaneous Determination of Pioglitazone HCl and Telmisartan in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2010;3(1):60-2.
16. Kotaiah MR, Ganesh B, Sekhar KB, Rasheed SH, Venkateswarlu Y, Dhandapani B. HPTLC Method Development and Validation for the Estimation of Trandolapril in Bulk and Its Formulations. Asian Journal of Research in Chemistry. 2010;3(1):158-60.
17. Patel GH, Prajapati ST, Patel CN. HPTLC Method development and validation for simultaneous determination of cinitapride and Pantoprazole in capsule dosage form. Research Journal of Pharmacy and Technology. 2011;4(9):1428-31.
18. Validation of analytical procedures: Text And Methodology Q2(R1). ICH Harmonised Tripartite Guideline 2005.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/St ep4/Q2_R1__Guideline.pdf (Last accessed on Dec. 2012)
19. Sudha T, Shanmugasundram P. Development and validation of RP-HPLC and HPTLC chromatographic methods of analysis for the quantitative estimation of raltegravir potassium in pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2011;4(11):1746-50.
20. Patel M. Development and validation of simultaneous estimation of two catecholamines in combine dosage form by HPTLC Method. Asian Journal of Pharmaceutical Analysis. 2014;4(2):57-77.
21. Agrawal H, Kaul N, Paradkar AR, Mahadik KR. Stability indicating HPTLC determination of clopidogrel bisulphate as bulk drug and in pharmaceutical dosage form. Talanta 2003; 61(5):581-9.
22. Andola HC, Purohit VK. High performance thin layer chromatography (HPTLC): A modern analytical tool for biological analysis. Nature and Science 2010; 8(10):58-61.