Malaysian Journal of Analytical Sciences Vol 19 No 6 (2015): 1156 - 1163

 

 

 

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC

METHOD FOR ESTIMATION OF DOLUTEGRAVIR SODIUM IN TABLET DOSAGE FORM

 

(Pembangunan dan Pengesahsahihan Kaedah Spektrofotometri UV bagi Anggaran Dolutegravir sodium dalam Bentuk Dos Tablet)

 

Bhavar Girija Balasaheb¹*, Aher Kiran Balasaheb², Thorat Ravindra Subhash², Kakadsachin Jijabapu²,

Pekamwar Sanjay Sudhakar³

 

¹Department of Pharmaceutical Chemistry

²Department of Quality Assurance Techniques

Amrutvahini College of Pharmacy, Sangamner, Maharashtra, India 422608.

³School of Pharmacy,

Swami Ramanand Teerth Marathwada University, Nanded Maharashtra, India 431606

 

*Corresponding author: girijabhavar@gmail.com

 

 

Received: 12 July 2015; Accepted: 8 October 2015

 

 

Abstract

A simple, rapid, precise and accurate spectrophotometric method has been developed for quantitative analysis of Dolutegravir sodium in tablet formulations. The initial stock solution of Dolutegravir sodium was prepared in methanol solvent and subsequent dilution was done in water. The standard solution of Dolutegravir sodium in water showed maximum absorption at wavelength 259.80 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 5–40 μg/mL with coefficient of correlation (R²) was 0.9992. The method was validated as per the ICH guidelines. The developed method can be adopted in routine analysis of Dolutegravir sodium in bulk or tablet dosage form and it involves relatively low cost solvents and no complex extraction techniques.

 

Keywords: dolutegravir sodium, UV spectrophotometry, validation, tablets

 

Abstrak

Satu kaedah spektrofotometri mudah, cepat, tepat dan jitu telah dibangunkan untuk analisis kuantitatif kandungan Dolutegravir sodium di dalam formulasi tablet. Larutan stok Dolutegravir sodium disediakan dalam pelarut methanol dan pencairan berikutnya dilakukan di dalam pelarut air. Larutan piawai Dolutegravir sodium di dalam air menunjukkan penyerapan maksimum pada jarak gelombang 259.80 nm. Ia  mematuhi hukum Beer - Lambert dalam julat kepekatan di antara 5 - 40 μg/mL dengan nilai pekali korelasi (R²) adalah 0.9992. Kaedah ini telah ditentusahkan mengikut garis panduan ICH. Kaedah ini boleh digunapakai dalam analisis rutin Dolutegravir sodium secara bentuk pukal atau juga dos tablet dan ia melibatkan pelarut kos yang rendah dan tidak memerlukan teknik pengekstrakan yang  kompleks.

 

Kata kunci: dolutegravir sodium, spektrofotometri UV, pengesahsahihan, tablet

 

References

1.       ViiV Healthcare, Tivicay® (dolutegravir) prescribing information. (2014), Research Triangle Park, NC.

2.       Castellino, S., Moss, L., Wagner, D. & et. al., (2013). Metabolism, excretion, and mass balance of the HIV-1 integrase inhibitor dolutegravir in humans. Antimicrobial Agents and Chemotherapy, 57: 3536 - 3546.

3.       Min, S., Song, I., Borland, J. Song I, Chen, S., Lou, Y., Min, S. S., Goljer, I., Culp, A., Piscitelli, S. C., Savina, P. M. (2010), Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrobial Agents and Chemotherapy, 54: 254 – 258.

4.       United State Food and Drug Administration, FDA (2013). Approves new drug to treat HIV infection http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm364744.htm [Access Online Aug. 12 2013].

5.       Kobayashi, M., Yoshinaga, T., Seki, T. Wakasa-Morimoto, C., Brown, K. W., Ferris, R., Foster, S. A., Hazen, R. J., Miki, S., Suyama-Kagitani, A., Kawauchi-Miki, S., Taishi, T., Kawasuji, T., Johns, B. A., Underwood, M. R., Garvey, E. P., Sato, A. and Fujiwara, T. (2011). In vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor. Antimicrobial Agents and Chemotherapy, 55: 813 – 821.

6.       Min, S., Sloan, L., De Jesus, E., Hawkins, T., McCurdy, L., Song, I., Stroder, R., Chen, S., Underwood, M., Fujiwara, T., Piscitelli, S. and Lalezari J. (2011). Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1-infected adults. AIDS, 25(14): 1737 – 1745.

7.       Reese, M. J., Savina, P. M., Generaux, G. T. and Tracey, H., Humphreys, J. E., Kanaoka, E., Webster, L. O., Harmon, K. A., Clarke, J. D. and Polli, J. W. (2013). In vitro investigations into the roles of drug transporters and metabolizing enzymes in the disposition and drug interactions of dolutegravir, a HIV integrase inhibitor. Drug Metabolism and Disposition, 41: 353 – 361.

8.       Castellino, S., Moss, L., Wagner, D., Borland, J. Song, I., Chen, S., Lou, Y., Min, S. S., Goljer, I., Culp, A., Piscitelli, S. C. and Savina, P. M. (2013). Metabolism, excretion, and mass balance of the HIV-1 integrase inhibitor, dolutegravir, in humans. Antimicrobial Agents and Chemotherapy, 57(8): 3536 – 3546.

9.       Bennetto-Hood, C., Tabolt, G., Savina, P. and Acosta, E. P. (2014). A sensitive HPLC-MS/MS method for the determination of dolutegravir in human plasma. Journal of Chromatography B- Analytical Technologies in the Biomedical and Life Sciences, 945 – 946: 225 - 232.

10.    Grégoirea, M., Deslandesa, G., Renauda, C., Bouquiéa, R., Allaenac, C., Raffic, F., Jollieta, P. and Dailly E. (2014), A liquid chromatography–tandem mass spectrometry assay for quantification of rilpivirine and dolutegravir in human plasma. Journal of Chromatography B- Analytical Technologies in the Biomedical and Life Sciences, 971: 1 – 9.

11.    International Conference on Harmonisation. ICH. (2005). ICH – Q2 (R1): Guideline on Validation of Analytical Procedure: Text and Methodology.

12.    International Conference on Harmonization, ICH. (2003). Q1A( R2): Stability testing of new drug substances and products.

13.    International Conference on Harmonization, ICH (2003). Q2 (R1): Validation of analytical procedures: test and methodology.