Author(s):
Sangeetha R K, Suganya S, Manju A S, Poomalai S
Email(s):
geetkaran@gmail.com
DOI:
10.52711/2231-5691.2024.00034 
Address:
Sangeetha R K*, Suganya S, Manju A S, Poomalai S
Department of Pharmaceutical Analysis, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore - 641 044.
*Corresponding Author
Published In:
Volume - 14,
Issue - 3,
Year - 2024
ABSTRACT:
Lamivudine is an anti-retroviral drug available in the formulation of tablets and oral solution. The selected compound Salicylic acid is categorized as Lamivudine impurity C. An HPTLC method was developed and validated for the estimation of Lamivudine in bulk and oral dosage forms. The chromatograms were developed using a mobile phase of methanol: water: ethyl acetate in the ratio 4:2:4, v/v/v on pre-coated plate of silica gel 60 F254 and quantified by densitometric absorbance mode at 233nm. The Rf values were 0.76±0.03 and 0.65±0.02 for Lamivudine and Salicylic acid respectively. The linearity was found to be within the range of 500-3000 ng/band for Lamivudine and 50-300ng/band for Salicylic acid. The lower limits of detection and quantification were 21.24ng/band and 64.37ng/band for Lamivudine and 8.47ng/band and 25.68ng/band for Salicylic acid. The statistical evaluation by the %RSD calculation for accuracy and precision were below 2. The validated method was applied to detect and quantify Salicylic acid in the tablets of two dosage forms and the oral solution prepared as admixture. The quantified amount of the impurity C was found to be within the limits in the tablets and not detectable in the oral solution. This method can be adopted to determine Lamivudine and its impurity C in the API and different dosage forms.
Cite this article:
Sangeetha R K, Suganya S, Manju A S, Poomalai S. Study on the Related Substance of Lamivudine by A Validated HPTLC Method in Oral Dosage Forms. Asian Journal of Pharmaceutical Research. 2024; 14(3):213-0. doi: 10.52711/2231-5691.2024.00034
Cite(Electronic):
Sangeetha R K, Suganya S, Manju A S, Poomalai S. Study on the Related Substance of Lamivudine by A Validated HPTLC Method in Oral Dosage Forms. Asian Journal of Pharmaceutical Research. 2024; 14(3):213-0. doi: 10.52711/2231-5691.2024.00034 Available on: https://asianjpr.com/AbstractView.aspx?PID=2024-14-3-3
REFERENCES:
1. Yelampalli, Suresh and Mallu, Useni and Kumar, J V and Pallepogu, Jyothi and Reddy, Gopa and Govindinne, Lakshmi. Development and validation of UPLC method for determination of lamivudine impurity profile in tablets. Asian Journal of Chemistry. 2018. 1065-1069. 10.14233.
2. Mondal P, Mahender K, Padmaja B. A novel UPLC-PDA method for the simultaneous determination of lamivudine, zidovudine and nevirapine in bulk and tablet dosage form. Analytical Chemistry Letters. 2018 Jan 2; 8(1):131-8.
3. Dhanve A, Rao JR, Dhale C. Development and validation of stability indicating HPTLC method for simultaneous estimation of lamivudine and dolutegravir sodium in bulk and pharmaceutical dosage formulation. IJPSR. 2018 Nov 1: (11):4701-8.
4. Bizimana T, Kayumba PC, Védaste K, Egide K, Kaale E. Development of high-performance thin layer chromatography for simultaneous analysis of lamivudine and tenofovir disoproxil fumarate. Rwanda Journal. 2016 Nov 1; 3(1):6-10.
5. Gopani, M., Patel, R.B., Patel, M.R. and Solanki, A.B. Development of a new high-performance thin layer chromatographic method for quantitative estimation of lamivudine and zidovudine in combined tablet dosage form using quality by design approach. Journal of Liquid Chromatography and Related Technologies. 2014; 37(17): 2420-2432.
6. Venkatesh P, Daggumati M. Development and validation of a normal-phase HPTLC method for the simultaneous analysis of lamivudine and zidovudine in fixed-dose combination tablets. Journal of Pharmaceutical Analysis. 2012 Apr 1; 2(2):152-5.
7. Rao NM, Sankar DG. Development and validation of stability-indicating HPLC method for simultaneous determination of Lamivudine, Tenofovir, and Dolutegravir in bulk and their tablet dosage form. Future Journal of Pharmaceutical Sciences. 2015 Dec 1:1(2): 73-7.
8. Karishma S, Subramaniam S, Muthuraman MS, Sivasubramanian A. RP-HPLC analytical method development and validation for lamivudine and zidovudine in pharmaceutical dosage forms. Int J Pharmtech Res. 2013: 5:1321-31.
9. Anandakumar K, Abirami G, Murugan S, Ashok B. RP-HPLC method for simultaneous estimation of lamivudine, tenofovir disoproxil fumarate and efavirenz in tablet formulation. Journal of Analytical Chemistry. 2013 Sep; 68(9): 815-21.
10. Gorja, A. and Bandla, J. Method development and validation for the simultaneous estimation of lamivudine and tenofovir disoproxil fumarate in pharmaceutical dosage forms by RP-HPLC. International Journal of Advanced Research in Pharmaceutical and Biomedical Sciences. 2011; 2(1): .22-32.
11. Balamuralikrishna K, Mahendra K, Syama Sundar B. Development and validation of analytical procedure for the simultaneous estimation of efavirenz, lamivudine and zidovudine through new RP-HPLC method. Journal of Pharmacy Research. 2011 Oct; 4(10): 3766-8.
12. Manikanta Kumar A, Naga B, Prasad VV, Diwan PV. Development and validation of UV Spectrophotometric method for simultaneous estimation of lamivudine and efavirenz in the pharmaceutical dosage form. Journal of Advanced Pharmacy Education and Research. 2012: 2(4).
13. Deepali G, Elvis M. UV Spectrophotometric method for assay of the anti-retroviral agent lamivudine in active pharmaceutical ingredient in its tablet formulation. Journal of Young Pharmacists. 2010 Oct 1; 2(4): 417-9.
14. Nagulwar VP, Bhusari KP. A validated UV spectrophotometric method for the simultaneous estimation of lamivudine, nevirapine and zidovudine in combined tablet dosage form. Journal of Pharmacy Research. 2009 Apr; 2(4): 666.
15. Guideline ICH. Validation of analytical procedures Q2 (R1). International conference of harmonization. Geneva, Switzerland 2022.
16. Venkatesh P, Daggumati M. Development and validation of a normal-phase HPTLC method for the simultaneous analysis of lamivudine and zidovudine in fixed-dose combination tablets. Journal of Pharmaceutical Analysis. 2012 Apr 1; 2(2):152-5.
17. G. Krishnamoorthy, N. Gayathri, M. Gnanaraja, R. Senthamarai. Assay of Lamivudine in Pharmaceutical Preparations by Spectrophotometric Method. Asian Journal of Pharmaceutical Analysis. 2012: 2(3)
18. S. Vidyadhara, RLC Sasidhar, B. Venkateswara Rao, P. Ratna Kumari. Simultaneous UV Spectrophotometric Method for the Determination of Tenofovir, Efavirenz and Lamivudine in Bulk and Combined Dosage Form. Asian Journal of Pharmaceutical Analysis. 2016: 6(4).
19. Mirza Shahed, Palaskar Pallavi S, MHG Dehghan, SN Mokale: Simultaneous Spectrophotometric Estimation of Abacavir sulfate and Lamivudine in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2009: 2(4)
20. V.P. Devmurari. Simultaneous Spectrophotometric Determination of Lamivudine and Abacavir in the Mixture. Asian Journal of Research in Chemistry. 2010:.2(3).
21. Lakshmi Aswini G., Dhachinamoorthi D., Prasada Rao CH. Visible Spectrophotometric Determination of Lamivudine in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2010: 3(4).
22. Jadhav S.D., Bhatia M.S., Thamake S.L., Pishawikar S. A Development and Validation of Method for Simultaneous Estimation of Lamivudine, Zidovudine and Nevirapine. Asian Journal of Research in Chemistry. 2010: 3(4).
23. Shinde G. S., Jadhav R. S., Vikhe D. N. Stability indicating Method development and Validation of Lamivudine, Zidovudine and Nevirapinein Tablet dosage form. Research Journal of Pharmaceutical Dosage Forms and Technology. 2022: 14(3).
24. Jitendra Verma, Dheeraj Jain, Nilesh Jain, Sharad P Pandey, Deepak Kumar Jain. Simultaneous Estimation of Lamivudine, Stavudine and Nevirapine by RP-HPLC in Tablet Formulation: Research Journal of Pharmacy and Technology. 2010: 3(2).
25. Controlled Porosity Osmotic Pump Tablets of Zidovudine and Lamivudine Combination: Optimization and Characterization. Research Journal of Pharmaceutical Dosage Forms and Technology. 2017 : 9(3).