Analytical method development and validation for estimation of dolutegravir in tablet dosage form
Keywords:
RP-HPLC, dolutegravir sodium, princeton C18, acetonitrile, methanolAbstract
A simple, specific, accurate, and precise reverse phase high performance liquid chromatography method was developed and validated to analyse Dolutegravir Sodium bulk dosage form. Using Princeton C18 HPLC column separation was carried out. This was maintained at 25ºC temperature. Shimadzu LC -20A prominence with LC solution softwarering separation mobile phase consist of Methanol: Water (0.1% OPA) in ratio of 80:20 v/v was delivered at a flow rate of 1mL/min. Using UV detector analysis was carried out at the wavelength 254 nm. RP-HPLC method was validated by using various parameter like system suitability, linearity, specificity, precision, limit of detection, limit of quantification and robustness. The RP-HPLC method was found to be linear over the concentration range from 10-60 µg/mL (r2 =0.9998). Retention time for bulk Dolutegravir Sodium was found to be 4.383 min. LOQ of method was 1.3274 µg/mL and LOD 0.4380 µg/mL. Thus the developed RP-HPLC method was found to be robust which can be applied for the regular analysis of Dolutegravir Sodium in the bulk as well as pharmaceutical dosage form.
Downloads
References
Khopkar S.M., Basic concepts of analytical chemistry, 2nd ed., New Age International Ltd. Publishers, New Delhi, 1998.
Skoog D.A., Holler F.J., Crouch S.R., Principle of Instrumental Analysis, 6th ed., Thomson Publications, India, 2007.
Katz, E. (2009) Quantitative Analysis Using Chromatographic Techniques, Wiley India Pvt. Ltd. p. 193 -211.
Connors, K. A.,(1999) Liquid Chromatography- A Textbook of Pharmaceutical Analysis, 3rd edn., Willey Inter Science, New York, p. 373-438.
Backett, A. H., Stenlake, J. B. (1997) Practical Pharmaceutical Chemistry, 4thedn., Part II, CBS Publications and Distributors, p. 1, 275-300.
Heftman, E. (2004) Chromatography- Fundamentals & applications of Chromatography and Related differential migration methods, 6thedn, Elsevier, Amsterdam, Vol. 69A, p. 253-291.
Sethi, P. D. (2001) Introduction – High-Performance Liquid Chromatography, 1stedn, CBS Publishers, New Delhi, p.1-28.
Swadesh, J. (1997) HPLC –Practical and Industrial Applications–CRC Press, Boca Raton, p. 20-25
Scott, P. W. (2001) Liquid Chromatography Column Theory, John Willey and Sons, Chi Chester, p. 1-13.
Gary, C. D. (2001) Analytical Chemistry, 5th edn. John Wiley & sons, Inc., p. 1- 3.
Snyder, L. R., Kirkland, J. J., Glajch, L. J.(1997) Practical HPLC Method Development, 2ndedn., John Wiley & sons, Inc, p. 21-57, 653-660.
Ahuja S. and M. W. Dong, “Handbook of Pharmaceutical Analysis by HPLC”, (2005); (I): 56-60.
K. B. Aher, R. S. Thorat, and S. R. Chaudhari, ''High-performance liquid chromatographic and method for the quantitative estimation of dolutegravir sodium in bulk drug and pharmaceutical dosage form,'' 2016, doi: 10.3797/scipharm.1507-09.
X. Wang, S. D. Penchala, A. Amara, L. Else, M. Mcclure, and M. Bof, '' A validated method for quantification of dolutegravir using ultra performance liquid chromatography coupled with uv detection,'' vol. 38, no. 3, pp. 327–331, 2016.
S. S. Dhanwate, A. D. Pachauri, P. D. Ghode, and K. R. Khandelwal, ''Development and validation of analytical method for the estimation of Lamivudine and Dolutegravir sodium in dosage form,'' vol. 11, no. 8, pp. 2886–2890, 2019.
D. D. R. M. Manisha, Dr. K. Bhavyasri, ''Method development , validation and forced degradation studies of tenofovir alafenamide fumarate in bulk and its pharmaceutical dosage,'' vol. XII, no. 10, pp. 300–308, 2019.
P. Sakinala, ''HPLC method development and validation of lamivudine , Journal of Global Trends in Pharmaceutical Sciences,'' no. May, 2020.
N. S. J. M. Venkatnarayana, ''Separation Techniques Development of Validation and Stability Indicating Method of Anti-HIV Dolutegravir Drug and its Related Impurities by Using RP-HPLC,'' pp. 1–7.
V. Mounika, D. Sivanarayana, and N. Pappula, ''International Journal of Research Publication and Reviews -Development and validation of new RP-UPLC method for simultaneous determination of lamivudine and dolutegravir in combined dosage form,'' no. 2, pp. 208–213, 2021. PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/Captisol 2021 (accessed 5 May. 2021).
D. Lakshman, K. N. Sree, N. Kumar, and S. A. Lewis, ''Investigation of drug-polymer miscibility , biorelevant dissolution , and bioavailability improvement of,'' 2019.
S. Mupparaju, V. Suryadevara, S. Doppalapudi, L. C. Sasidhar Reddyvallam, R. Anne, and S. S. Sunkara, ''Formulation and evaluation of telmisartan fast dissolving tablets using jack fruit seed starch as superdisintegrant,'' Int. J. Appl. Pharm., vol. 11, no. 5, pp. 25–32, 2019.
H. A. Abou-Taleb, Z. Fathalla, and H. Abdelkader, ''Comparative studies of the effects of novel excipients amino acids with cyclodextrins on enhancement of dissolution and oral bioavailability of the non-ionizable drug carbamazepine,'' Eur. J. Pharm. Sci., vol. 155, no. September, p. 105562.
T. Agrawal and U. Lade, ''A review on solid dispersion method to increases the
solubility,'' vol. 6, no. 2, pp. 44–49, 2020.
D. C. Complexes, P. Saokham, C. Muankaew, and P. Jansook, ''Solubility of Cyclodextrins and,'' pp. 1–15.
K. B. Aher, R. S. Thorat, and S. R. Chaudhari, ''High-performance liquid chromatographic and method for the quantitative estimation of dolutegravir sodium in bulk drug and pharmaceutical dosage form,'' 2016.
X. Wang, S. D. Penchala, A. Amara, L. Else, M. Mcclure, and M. Bof, '' A validated method for quantification of dolutegravir using ultra performance liquid chromatography coupled with uv detection,'' vol. 38, no. 3, pp. 327–331, 2016.
S. S. Dhanwate, A. D. Pachauri, P. D. Ghode, and K. R. Khandelwal, ''Development and validation of analytical method for the estimation of Lamivudine and Dolutegravir sodium in dosage form,'' vol. 11, no. 8, pp. 2886–2890, 2019.
D. D. R. M. Manisha, Dr. K. Bhavyasri, ''Method development , validation and forced degradation studies of tenofovir alafenamide fumarate in bulk and its pharmaceutical dosage,'' vol. XII, no. 10, pp. 300–308, 2019. P. Sakinala, ''HPLC method development and validation of lamivudine , Journal of Global Trends in Pharmaceutical Sciences,'' no. May, 2020.
N. S. J. M. Venkatnarayana, ''Separation Techniques Development of Validation and Stability Indicating Method of Anti-HIV Dolutegravir Drug and its Related Impurities by Using RP-HPLC,'' pp. 1–7.
V. Mounika, D. Sivanarayana, and N. Pappula, ''International Journal of Research Publication and Reviews -Development and validation of new RP-UPLC method for simultaneous determination of lamivudine and dolutegravir in combined dosage form,'' no. 2, pp. 208–213, 2021.
B. Sillman, A. Bade, P. Dash, B. Bhargavan, ''Creation of a long- acting nano formulated dolutegravir, '' pp. 1-14, 2018.
S. Mupparaju, V. Suryadevara, S. Doppalapudi, L. C. Sasidhar Reddyvallam, R. Anne, and S. S. Sunkara, ''Formulation and evaluation of telmisartan fast dissolving tablets using jack fruit seed starch as superdisintegrant,'' Int. J. Appl. Pharm., vol. 11, no. 5, pp. 25–32, 2019.
S. M. Badr-eldin, S. A. Elkheshen, and M. M. Ghorab, ''Inclusion complexes of tadalafil with natural and chemically modified b -cyclodextrins . I : Preparation and in-vitro evaluation,'' Eur. J. Pharm. Biopharm., vol. 70, no. 3, pp. 819–827, 2008.
W. Zhang, G. Wang, J. R. Falconer, B. C. Baguley, and P. John, ''Strategies to maximize Department of Pharmaceutical Sciences, R.T.M. Nagpur University, Nagpur 5110. liposomal drug loading for a poorly water-soluble anticancer drug,'' 2014.
P. Jansook, N. Ogawa, and T. Loftsson, ''Cyclodextrins : structure , physicochemical properties and pharmaceutical applications,'' Int. J. Pharm., vol. 535, no. 1–2, pp. 272– 284, 2018.
H. A. Abou-Taleb, Z. Fathalla, and H. Abdelkader, ''Comparative studies of the effects of novel excipients amino acids with cyclodextrins on enhancement of dissolution and oral bioavailability of the non-ionizable drug carbamazepine,'' Eur. J. Pharm. Sci., vol. 155, no. September, p. 105562, 2020.
M. L. Cottrell, T. Hadzic, and A. D. M. Kashuba, ''Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir,'' pp. 981–994, 2013, doi: 10.1007/s40262-013-0093-2. Dolutegravir sodium, PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/Dolutegravir 2021 (accessed 18 May. 2021).
Dolutegravir sodium, drug bank, https://www.drugbank.ca/drugs/DB08930 2021 (accessed 18 JUNE. 2021). S. Castellino, L. Mose, D. Wagner, J. Borland, S. Chen, ''In humans metabolism , excretion , and mass balance of the hiv-1 integrase inhibitor dolutegravir in humans,'' 2013.
L. Elzi, S. Erb, H. Furrer, M. Cavassini, A. Calmy, ''Adverse events of raltegravir and dolutegravir,'' Aids, vol. 31, no. 13, pp. 1853–1858, 2017.
PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/Captisol 2021 (accessed 5 May . 2021).
S. K. Jena, C. Singh, C. P. Dora, and S. Suresh, ''Development of tamoxifenphospholipid complex: Novel approach for improving solubility and bioavailability,'' Int. J. Pharm., vol. 473, no. 1–2, pp. 1–9, 2014.
C. Mack, D. Gupta, and N. A. Raut, ''The role of phospholipid as a solubility-and permeability-enhancing excipient for the improved delivery of the bioactive phytoconstituents of Bacopa monnieri'' European Journal of Pharmaceutical Sciences, Elsevier B.V, pp. 1-13, 2016.
D. D. R. M. Manisha, Dr. K. Bhavyasri, ''Method development , validation and forced degradation studies of tenofovir alafenamide fumarate in bulk and its pharmaceutical dosage,'' vol. XII, no. 10, pp. 300–308, 2019.
P. Sakinala, ''HPLC method development and validation of lamivudine , Journal of Global Trends in Pharmaceutical Sciences,'' no. May, 2020.
N. S. J. M. Venkatnarayana, ''Separation Techniques Development of Validation and Stability Indicating Method of Anti-HIV Dolutegravir Drug and its Related Impurities by Using RP-HPLC,'' pp. 1–7.
V. Mounika, D. Sivanarayana, and N. Pappula, ''International Journal of Research Publication and Reviews -Development and validation of new RP-UPLC method for simultaneous determination of lamivudine and dolutegravir in combined dosage form,'' no. 2, pp. 208–213, 2021.
PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/Captisol 2021 (accessed 5 May. 2021).
Widana, I.K., Sumetri, N.W., Sutapa, I.K., Suryasa, W. (2021). Anthropometric measures for better cardiovascular and musculoskeletal health. Computer Applications in Engineering Education, 29(3), 550–561. https://doi.org/10.1002/cae.22202
Published
How to Cite
Issue
Section
Copyright (c) 2022 International journal of health sciences
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the International Journal of Health Sciences (IJHS) are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJHS right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.
Articles published in IJHS can be copied, communicated and shared in their published form for non-commercial purposes provided full attribution is given to the author and the journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
This copyright notice applies to articles published in IJHS volumes 4 onwards. Please read about the copyright notices for previous volumes under Journal History.
