ABSTRACT:
A simple, precise, accurate High-performance thin-layer chromatography (HPTLC) method has been developed and validated for the estimation of escitalopram oxalate (ESC) and flupentixol dihydrochloride (FLU) in pharmaceutical formulation. Separation was achieved on an aluminum HPTLC plate coated with a 0.2 mm layer of silica gel 60 F254 with chloroform: methanol 4:6 (v/v) as mobile phase. The densitometry analysis was carried out in absorbance mode at 254 nm. The Rf values of escitalopram and flupentixol were 0.24 and 0.44 respectively. The linearity of the method was achieved in the range 3-7 µg/spot for ESC with correlation coefficient value 0.998 and 0.3-0.7µg/spot for FLU with correlation coefficient value 0.999. The developed method was validated according to ICH guidelines and the results were statistically validated. The limit of detection and quantification for escitalopram oxalate and flupentixol dihydrochloride was found to be 500 ng/spot and 50 ng/spot, 1000 ng/spot, and 100 ng/spot respectively.
Cite this article:
S. Malathi, H. Ananthi. Development and Validation of HPTLC Method for the Estimation of Escitalopram oxalate and Flupentixol Dihydrochloride in Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2022; 15(11):5255-9. doi: 10.52711/0974-360X.2022.00885
Cite(Electronic):
S. Malathi, H. Ananthi. Development and Validation of HPTLC Method for the Estimation of Escitalopram oxalate and Flupentixol Dihydrochloride in Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2022; 15(11):5255-9. doi: 10.52711/0974-360X.2022.00885 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-11-70
REFERENCES:
1. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, India 2014; Vol-II, 1797.
2. British Pharmacopeia. H.M. Stationary Office, London 2012; Vol-I, 944.
3. Supriya T, Naresh D, Kumar GV, Haneef MA. Stability indicating RP-HPLC method development and validation for simultaneous estimation of escitalopram and flupentixol in pure and marketed formulation. Asian Journal of Pharmaceutical Research. 2018; 8(1): 4-10.
4. Patel NJ, Patel B, Patel K, Patel J, Siddhanti K. Validation study for simultaneous estimation of escitalopram oxalate and flupentixol hydrochloride in tablet dosage form by HPLC. World Journal of Pharmaceutical Research. 2017; 1388-96.
5. Naresh D, Patel D. Stability indicating chromatographic method development and validation for the simultaneous estimation of escitalopram oxalate and flupentixol in its pharmaceutical dosage form by HPLC. World Journal of Pharmaceutical Research. 2017; 549-66.
6. Malathi S, Darthi D. Simultaneous UV spectrophotometric method for estimation of escitalopram oxalate and flupentixol dihydrochloride in tablet dosage form. International. Journal of Chemtech Research. 2018; 11(06): 134-138.
7. Vetrichelvan T, Arul K, Sumithra M, Umadevi B. Colorimetric method for the estimation of escitalopram oxalate in tablet dosage form. Indian Journal of Pharmaceutical Sciences. 2010; 72(2): 269-271.
8. Singh Pinki, Dhara Patel, Sharavdesai. First order spectrophotometric method for simultaneous estimation of Escitalopram oxalate and Flupentixol dihydrochloride in pharmaceutical dosage from. Indo American Journal of Pharmaceutical sciences. 2016; 4544-53.
9. Shivani C Patel, Dilip G. Maheshar. Development and validation of UV Spectrophotometric and HPLC method for estimation oxalate and flupentixol dihydrochloride in combined dosage form. Asian journal of pharmaceutical Technology and Innovation. 2016; 4 (17):59-70.
10. Ratna S.Limgavkar RS, Trivedi PD, Patel AJ. Development and validation of reverse phase high-performance liquid chromatographic and high-performance thin-layer chromatographic methods for simultaneous estimation of melitracen hydrochloride and flupentixol hydrochloride in bulk and combined dosage form. Journal of Liquid Chromatography &Related Technologies. 2012; 5(19):2753-64.
11. Rajendrakakde, Dineshsatone. HPTLC method for simultaneous analysis of escitalopram and Clonazepam in pharmaceutical preparations. Journal of Planar Chromatography. 2009; 22 (6):417-20.
12. Usmangani k, Chhalotiya UK. Development of LC method for the simultaneous determination of antidepressant drug combination melitracen hydrochloride and flupentixol dihydrochloride in their combined dosage form. Chromatography Research International. 2011; 36:1-6.
13. Sethi PD. HPTLC high performance thin layer chromatography quantitative analysis of pharmaceutical formulations. 2001.
14. Validation of analytical procedures; methodology Q2B (1996) ICH harmonized. Tripartite guideline 1-8.