Malaysian Journal of Analytical Sciences Vol 19 No 5 (2015): 920 - 929

 

 

 

SPECTROPHOTOMETRIC QUANTIFICATION OF VILAZODONE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM USING QUALITY BY DESIGN APPROACH

 

(Kuantifikasi Spektrofotometri Vilazodon Hidroklorida dalam Bentuk Dos Farmaseutikal Menggunakan Pendekatan Reka Bentuk Kualiti)

 

Sagar Suman Panda¹*, Bera Venkata Varaha Ravi Kumar¹, Sarwar Beg ², Soumyajit Behera¹

 

¹Department of Pharmaceutical Analysis and Quality Assurance

²Department of Pharmaceutics

Roland Institute of Pharmaceutical Sciences, Khodasingi, Berhampur-760010, Odisha, India

 

*Corresponding author: sagarguddu2002@gmail.com

 

 

Received: 26 June 2015; Accepted: 3 August 2015

 

 

Abstract

The present work deals with development and validation of a novel, robust, precise and accurate spectrophotometric method, for the estimation of vilazodone hydrochloride in tablets using the principle of Quality by Design (QbD). A fractional factorial design (FFD) was employed for initial parameter screening. Further the screened parameters were subjected to central composite design (CCD) for evaluating method robustness and method optimization. Different statistical parameters were evaluated to decide appropriateness of experimental data. Vilazodone shows absorption maximum at 285nm using methanol. Factor screening slit width and sampling interval were identified as critical method variables, which were further evaluated by a CCD. Good linearity was obtained for vilazodone in the range of 5-60 μg/mL with R² > 0.999. The method was found to be accurate with good average % recovery (more than 100%). Developed method was validated as per ICH guidelines. Based on QbD development of spectrophotometric method ensured that quality is built into the method. The method was robust and can be applied for determination of the vilazodone in pharmaceutical dosage form.

 

Keywords: vilazodone hydrochloride, spectrophotometric, quality by design, validation

 

Abstrak

Kajian ini melibatkan pembangunan dan validasi kaedah spektrofotometri yang asli, teguh, jitu dan tepat bagi anggaran kandungan vilazodon hidroklorida di dalam tablet dalam menggunakan prinsip reka bentuk kualiti (QbD). Satu reka bentuk faktor pecahan (FFD) telah digunakan untuk saringan awal parameter. Selanjutnya parameter yang diuji adalah tertakluk kepada analisis reka bentuk komposit berpusat (CCD) untuk menilai pengoptimunan dan keteguhan. Ujian statistik yang berbeza telah dinilai untuk menentukan kesesuaian data eksperimen. Vilazodon menunjukkan penyerapan maksimum pada 285nm menggunakan metanol. Saringan faktor lebar celah dan selang pensampelan telah dikenal pasti sebagai pembolehubah yang kritikal, yang kemudian dinilai lebih lanjut melalui CCD. Kelinearan baik telah diperolehi bagi vilazodon bagi julat di antara 5-60 μg/mL dengan R2 > 0.999. Kaedah ini didapati tepat dengan % perolehan semula mencapai skor yang baik (lebih daripada 100 %). Kaedah telah ditentusahkan menurut peraturan ICH. Berdasarkan pembangunan QbD terhadap kaedah spektrofotometri, ia dipastikan bahawa kualiti analisis terbina ke dalam kaedah ini. Kaedah ini adalah teguh dan boleh digunakan untuk penentuan vilazodon dalam bentuk dos farmaseutikal.

Kata kunci: vilazodon hidroklorida, spektrofotometri, reka bentuk kualiti, validasi

References

1.       Pierz, K. A. and Thase, M. E (2014). A review of vilazodone, serotonin and major depressive disorder. The Primary Care Companion for CNS Disorders 16(1): PCC.13r01554.

2.       Cruz, M. P. (2012). Vilazodone HCl (Vibryd): A serotonin partial agonist and reuptake inhibitor for the treatment of major depressive disorder. Pharmacy and Therapeutics 37(1):28-31.

3.       Khan, A., Sambunaris, A., Edwards, J., Ruth, A. and Robinson, D. S. (2014). Vilazodone in the treatment of major depressive disorder: efficacy across symptoms and severity of depression. International Clinical Psychopharmacology, 29(2):86-92.

4.       Schwartz, T. L., Siddiqui, U. A. and Stahl, S. M. (2011). Vilazodone: a brief pharmacological and clinical review of the novel serotonin partial agonist and reuptake inhibitor. Therapeutic Advances in Psychopharmacology 1(3): 81-87.

5.       Edwards, J., Chen, D., Ruth, A. and Thase, M.E. (2013). Vilazodone improves anxiety symptoms in patients with major depressive disorder: a pooled analysis of efficacy. Abstracts of the 26^th ECNP Congress. European Journal of Neuropsychopharmacology 23(S2): S325-326.

6.       Jain, R., Chen, D., Edwards, J. and Mathews, M. (2013). Early improvement and sustained response with vilazodone in patients with major depressive disorder – pooled analyses from phase III trials. Abstracts of the 26th ECNP Congress. European Journal of Neuropsychopharmacology 23(S2): S326.

7.       Oosting, R.S., Chan, J., Olivier, P. and Banerjee, P. (2013)  Vilazodone exhibits a favorable sexual profile in male rats. Abstracts of the 26th ECNP Congress. European Journal of Neuropsychopharmacology 23(S2): S205.

8.       Ghosh, S., Bomma, S., Prasanna, V. L. and Banji, D. (2014). Development of validated UV spectrophotometric method for the estimation of vilazodone hydrochloride. International Journal of Drug Development and Research, 6(1): 169-174.

9.       Reddy, B. P., Pramod, N., Rao, P.V. and Babu, A. M. S. S. (2012). Method development and validation for the assay of vilazodone in bulk and formulation by using rp-hplc technique. International Journal of Biological and Pharmaceutical Research 3(6):789-795.

10.    El-Bagary, R. I., Hashem, H. A. E. M., Fouad, M. A. and Mahmoud, S. T. (2014). Development and Validation of Spectrofluorimetric and RP-HPLC with Fluorimetric Detection Methods for the Determination of Vilazodone in Bulk and Pharmaceutical Preparation. International Journal of Pharmaceutical Research Scholars 3(2): 113-119.

11.    Sui, W., Yang, X., Yu, W., Jin, Y., Luan, X., Wang, X. and Xu, H. (2014). A validated LC-MS/MS method for the rapid quantification of vilazodone in rat plasma: Application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis 98: 228-234.

12.    Godfrey, A.B. and Kenett, R. S. (2007). Joseph M. Juran, a perspective on past contributions and future impact. Quality and Reliability Engineering International, 23(6): 653–663.

13.    Pharmaceutical cGMPS for the 21^st Century – A Risk-Based Approach: Second Progress report and Implementation Plan (2003) Online Access: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836.

14.    Nethercote, P., Borman, P., T. Bennett, Martin, G. and McGregor, P. (2010).QbD for Better Method Validation & Transfer. Online Access: http://www.pharmamanufacturing.com/articles/2010/060/.

15.    Bianchini, R. M., Castellano, P.M. and Kaufman, T. S. (2009). Development and validation of an HPLC method for the determination of process-related impurities in pridinol mesylate, employing experimental designs. Analytica Chimica Acta 654(2): 141-147.

16.    Ye, C., Liu, J., Ren, F. and Okafo, N. (2000). Design of experiment and data analysis by JMP (SAS institute) in analytical method validation. Journal of Pharmaceutical and Biomedical Analysis 23(2-3):581-589.

17.    Space, J. S., Opio, A. M., Nickerson, B., Jiang, H., Dumont, M. and Berry, M. (2007). Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets. Journal of Pharmaceutical and Biomedical Analysis 44(5): 1064-1071.

18.    Beg, .S, Kohli, K., Swain, S. and Hasnain, M. S. (2012). Development and validation of RP-HPLC method for quantitation of amoxicillin trihydrate in bulk and pharmaceutical formulations using Box-Behnken experimental design. Journal of Liquid Chromatography & Related Technology 35(3):393-406.

19.    Validation of Analytical Procedures: Text and Methodology, ICH Harmonized Tripartite Guideline, (2005), pp 1-13.