DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ESCITALOPRAM OXALATE AND FLUPENTIXOL DIHYDROCHLORIDE IN COMBINED DOSAGE FORM AND PLASMA

  • MALATHI SELLAPPAN Department of Pharmaceutical Analysis, PSG College of Pharmacy, Peelamedu, Coimbatore, Tamilnadu, 641004, India
  • DARTHI DEVAKUMAR Department of Pharmaceutical Analysis, PSG College of Pharmacy, Peelamedu, Coimbatore, Tamilnadu, 641004, India

Abstract

Objective: The objective of the study was to develop a simple and rapid chromatographic method for quantification of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form and plasma.


Methods: The separation was achieved with a sun fire C8 [150×4.6 mm] 3.5 µm column with an isocratic mobile phase containing a mixture of potassium dihydrogen orthophosphate buffer: methanol: acetonitrile [30:60:10 v/v/v] pH adjusted to 11. The flow rate of the mobile phase was 1.5 ml/min with a Photodiode array [PDA] detection at 230 nm.


Results: The HPLC method was developed and validated with respective linearity, accuracy, and precision, detection of limit, robustness, and specificity. The precision of the results stated as the relative standard deviation was below 2 %. The calibration curve was linear over a concentration range from 10-50 µg/ml for escitalopram oxalate and 1-5 µg/ml for flupentixol dihydrochloride with a correlation co-efficient 0.994 and 0.977 respectively. The accuracy of the method was demonstrated at levels in the range of 100 % and 120 % of the specification limit. The recovery of escitalopram oxalate and flupentixol dihydrochloride was found to be in the range of 90 % to 88 %, respectively. The lowest detection limits were found to be 2 µg/ml for escitalopram oxalate and 0.1 µg/ml for flupentixol dihydrochloride. The lowest quantification limits were found to be 5 µg/ml of escitalopram oxalate and 0.5 µg/ml of flupentixol dihydrochloride.


Conclusion: The developed method was validated for linearity, accuracy, precision, the limit of detection and quantification, specificity. The method was applied successfully for the determination of escitalopram oxalate and flupentixol dihydrochloride in the combined dosage form and plasma.

Keywords: Escitalopram oxalate, Flupentixol dihydrochloride, High-performance liquid chromatography, Human plasma, Validation

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References

1. Indian pharmacopoeia. Vol. II. The government of India, Ministry of health and Family Welfare. The Indian pharmacopoeia commission, Ghaziabad; 2014. p. 1685.
2. Indian pharmacopoeia. Vol. II. The government of India, Ministry of Health and Family Welfare. The Indian pharmacopoeia commission. Ghaziabad; 2014. p. 1797.
3. Rajendra B Kakde, Dinesh D Satone, Kamalesh K Gadapayale, Megha G Kakde. Stability indicating RP-HPLC method for the simultaneous determination of escitalopram oxalate and clonazepam. J Chromatogr Sci 2013;51:490-5.
4. Prasenjit Mondal, Santhosh B, Sobha Rani Satla, Ramakrishna Raparla. A new validated simultaneous RP-HPLC method for estimation of escitalopram oxalate and etizolam in bulk and tablet dosage form. Der Pharma Chemica 2013;5:26-32.
5. Kanji Fatema, Zakiur Rahman, Subrata Kumar, Biswas, Suraia Aktar. Development UV spectroscopic method for nefopam and escitalopram as INN drugs in the tablet dosage form. S J Pharm Sci 2010;3:4-10.
6. Usmangani K, Chhalotiya Kashyap, K Bhatt, Dimal A Shah, Gautam R Chauhan, Sunil L Baldania. Development of LC method for the simultaneous determination of antidepressant drug combination melitracen hydrochloride and flupentixol dihydrochloride in their combined dosage form. Chromatogr Res Int 2011;1-6. https://doi.org/10.4061/2011/632820
7. Syed Muddasir Hussain, Mohammed Aqeel, Syed Ajman Hussain. Validated spectrometric method for simultaneous estimation of flupentixol and melitracen in the combined dosage form. Int J Pharm Tech Res 2013;5:1493-7.
8. Mohd Yunus HH, Siddiqui, Paramdeep Bagga, Md Ahmad Ali, Kuldeep Singh. A simple UV spectrometric method for the determination of flupentixol dihydrochloride in bulk pharmaceutical formulation. IJPSR 2011;2:2152-5.
9. Akhil Nagar, Naresh N Chugh. Simultaneous estimation method development as an analytical method for flupentixol dihydrochloride and melitracen hydrochloride from their combined pharmaceutical dosage forms by RP-HPLC. Pharma Innovation J 2015;4:81-6.
10. El-Enany N, Belal F, El-Brashy A, El-Bahy N. Spectrofluorimetric determination of flupentixol dihydrochloride and quetiapine in pharmaceutical preparations and spiked human plasma via oxidation with cerium [IV]. ACAIJ 2009;8:325-33.
11. Damor Sheetal Ben Nareshkumar, Darpini Patel. Stability indicating chromatographic method development and validation for the simultaneous estimation of escitalopram oxalate and flupentixol in its pharmaceutical dosage form by HPLC. WJPR 2017;6:549-66.
12. Supriya T, Naresh D, Vijaya Kumar G, Haneer MA. Stability indicating RP-HPLC method development and validation for simultaneous estimation of escitalopram and flupentixol pure and marketed formulation. Asian J Pharm Res 2018;8:4-10.
13. Shivani C Patel, Dilip G Maheshwari. Development and validation of UV spectrometric and HPLC method for estimation of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form. AJPTI 2016;4:59-70.
14. Singh Pinki, Dhara Patel, Dhananjay Mesbram, Sharav Desai. First-order spectrophotometric method for simultaneous estimation of escitalopram oxalate and flupentixol dihydrochloride in the pharmaceutical dosage form. IAJPR 2016;6:4544-53.
15. International Conference on Harmonization [ICH Q2B]. Guidelines on Validation of Analytical procedures: Text and Methodology. International Conference on Harmonization IFPMA, Geneva, Switzerland; 2005.
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SELLAPPAN, M., and D. DEVAKUMAR. “DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ESCITALOPRAM OXALATE AND FLUPENTIXOL DIHYDROCHLORIDE IN COMBINED DOSAGE FORM AND PLASMA”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 13, no. 2, Feb. 2021, pp. 61-66, doi:10.22159/ijpps.2021v13i2.30158.
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