Author(s):
Indu Singh, Kinjal Parmar, Sweta Patel
Email(s):
kinjalparmar0110@gmail.com , kinjal.parmar19149@paruluniversity.ac.in
DOI:
10.52711/0974-360X.2026.00409 
Address:
Indu Singh1 , Kinjal Parmar2*, Sweta Patel3
1Research scholar, Department of Pharmaceutical Analysis, Parul Institute of Pharmacy and Research, Parul University,Vadodara- 391760 Gujarat, India.
2Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy and Research, Parul University, Vadodara- 391760 Gujarat, India.
3Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy and Research, Parul University, Vadodara- 391760 Gujarat, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 6,
Year - 2026
ABSTRACT:
A easy to understand quick, reliable, and selective HPTLC method for identifying stability has been created and verified for the simultaneous estimation of Chlorthalidone and Benidipine Hydrochloride in a pharmaceutical dose form. Benidipine Hydrochloride and Chlorthalidone are now approved at 4mg, 12.5mg, and 4mg, 6.25mg on CDSCO's revised combination approval list for the treatment of hypertension, or high blood pressure. Ethyl Acetate: n-hexane (7:3 v/v) was used as the mobile phase and HPTLC Silica gel 60 F254 aluminum sheets as the stationary phase in order to resolve the medications. A wavelength of 238 nm was selected from the Benidipine Hydrochloride spectrum in order to use HPTLC analysis to detect the drug. Additionally, a wavelength of 271 nm was selected from the Chlorthalidone spectra using HPTLC analysis in order to identify the drug. For Benidipine Hydrochloride, the Rf value was 0.704, and for Chlorthalidone, it was 0.421. The following plots were made of the concentration ranges for Benidipine Hydrochloride and Chlorthalidone: 1000–5000 ng/spot and 3125–15625 ng/spot, respectively. The HPTLC technique was validated in accordance with ICH guidelines, and it was discovered that the linearity, precision, accuracy, robustness, and LOD/LOQ System appropriateness scores satisfied the acceptance requirements. The stability experiments were carried out under forced degradation circumstances, including acid degradation, base degradation, oxidative hydrolysis, thermal degradation, and photolytic degradation. Both drugs were shown to be susceptible to the degradation conditions and to have well-resolved conventional drug peaks.
Cite this article:
Indu Singh, Kinjal Parmar, Sweta Patel. Development and Validation of Stability Indicating HPTLC Method for Simultaneous Estimation of Benidipine Hydrochloride and Chlorthalidone in Pharmaceutical dosage form. Research Journal Pharmacy and Technology. 2026;19(6):2869-5. doi: 10.52711/0974-360X.2026.00409
Cite(Electronic):
Indu Singh, Kinjal Parmar, Sweta Patel. Development and Validation of Stability Indicating HPTLC Method for Simultaneous Estimation of Benidipine Hydrochloride and Chlorthalidone in Pharmaceutical dosage form. Research Journal Pharmacy and Technology. 2026;19(6):2869-5. doi: 10.52711/0974-360X.2026.00409 Available on: https://rjptonline.org/AbstractView.aspx?PID=2026-19-6-66
7. REFERENCES:
1. Hermansen K. Diet, blood pressure and hypertension. Br J Nutr. 2000 Jun; 83(S1): S113–9. doi:10.1017/S0007114500001045
2. Yao K, Nagashima K, Miki H. Pharmacological, pharmacokinetic, and clinical properties of benidipine hydrochloride, a novel long-acting calcium channel blocker. J Pharmacol Sci. 2006; 100(4):243–61.
3. Public Health Notes. Hypertension: Living with hypertension [Internet]. Available from: https://www.publichealthnotes.com/hypertension/living-with-hypertension-diagram-768x643
4. Yukti R, Shah T, Modi N, Dutiya R, Chauhan N, Mandale D. A review article on analytical methods for combination of drugs benidipine hydrochloride and telmisartan. World J Pharm Res. 2024 May; 83:804–30. doi:10.20959/wjpr202411-32673
5. DrugBank. Benidipine Hydrochloride: Drug profile [Internet]. Available from: https://go.drugbank.com/drugs/DB09231
6. Roush GC, Buddharaju V, Ernst ME, Holford TR. Chlorthalidone: mechanisms of action and effect on cardiovascular events. Curr Hypertens Rep. 2013 Oct; 15:514–21.
7. DrugBank. Chlorthalidone: Drug profile [Internet]. Available from: https://go.drugbank.com/drugs/DB00310
8. Roush GC, Buddharaju V, Ernst ME, Holford TR. Chlorthalidone: mechanisms of action and effect on cardiovascular events. Curr Hypertens Rep. 2013 Oct; 15: 514–21. doi:10.1007/s11906-013-0372-1
9. Blessy MR, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014 Jun; 4(3):159–65. doi:10.1016/j.jpha.2013.09.003
10. Sharma MK, Murugesan M. Forced degradation study: an essential approach to develop stability indicating method. J Chromatogr Sep Tech. 2017 Jan 27; 8(1): 349. doi:10.4172/2157-7064.1000349
11. Janzen H. Forced degradation studies – Comparison between ICH, EMA, FDA and WHO guidelines and ANVISA’s resolution RDC 53/2015. Unpublished manuscript. 1–51.
12. Sangle S, Deshpande P, Shinde N, Tayade V. Development and validation of stability indicating HPTLC method for simultaneous determination of olmesartan medoxomil and chlorthalidone in combined tablet dosage forms. Eur J Pharm Med Res. 2014; 4:574–81.
13. Potale LV, Damle MC, Khodke AS, Bothara KG. A validated stability indicating HPTLC method for simultaneous estimation of ramipril and telmisartan. Int J Pharm Sci Rev Res. 2010 May ;(2):35–9.
14. Singh SU, Patel KU, Agarwal VK, Chaturvedi SH. Stability indicating HPTLC method for simultaneous determination of valsartan and hydrochlorothiazide in tablets. Int J Pharm Pharm Sci. 2012;4(4):468–71.
15. Blessy MR, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014;4(3):159–65.
16. Sharma MK, Murugesan M. Forced degradation study: an essential approach to develop stability indicating method. J Chromatogr Sep Tech. 2017;8(1):349.
17. Mohanbhai PL, Mustaqhusen MS, Kamleshbhai JA, Liyakatali KM. Spectrophotometric method for the determination of Benidipine Hydrochloride in pharmaceutical formulation. Trop J Pharm Life Sci. 2018:1–7.
18. Rathod RH, Patil AS, Shirkhedkar AA. Novel NP and RP-HPTLC in praxis for simultaneous estimation of Chlorthalidone and Cilnidipine in bulk and pharmaceutical formulation. Anal Chem Lett. 2018:862–71.
19. Raveendran KC, Seethalp S. High Performance Thin Layer Chromatography of simultaneous estimation of Cilnidipine Hydrochloride and Chlorthalidone in its combined dosage forms. World. 2024:216–33.
20. International Conference on Harmonisation (ICH). Validation of analytical procedures: Text and methodology Q2(R1) 2005. Available from: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
21. Dhandapani B, Anjaneyulu N, Kumar KV, Rasheed SH, Ramakotaiah M. HPTLC Method Development and Validation for the Estimation of Rabeprazole Sodium and Itopride Hydrochloride in Tablet Dosage Form. Res J Pharm Technol. 2010;3(2):475–7.
22. Rao NM, Bagyalakshmi J, Ravi TK. Development and Validation of an Analytical Method for the Estimation of Standard Cholesterol and Egg Cholesterol by High Performance Thin Layer Chromatography (HPTLC). Res J Pharm Technol. 2011;4(1):155–9.
23. Raval HV, Patel DM, Patel CN. Estimation of Metoprolol Tartrate and Chlorthalidone in Combined Dosage Form by UV-Spectrophotometric Methods. Res J Pharm Technol. 2011;4(7):1132–4.
24. Mathew N, Jacob JT. Stability Profiling of Amodiaquine under stress Degradation Conditions. Res J Pharm Technol. 2019;12(8):3807–10.
25. Kumar SA, Debnath M, Rao JVLN, Sankar DG. Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in Bulk as well as in Pharmaceutical Dosage Form by using RP-HPLC. Res J Pharm Technol. 2014;7(9):1004–13.
26. Deshpande PB, Butle SR. Development and Validation of Stability-Indicating RP-HPLC Method for Determination of Atazanavir and Ritonavir. Res J Pharm Technol. 2014;7(11):1231–6.
27. Sutar SV, Yeligar VC, Patil SS. Stability Indicating Forced Degradation Studies. Res J Pharm Technol. 2019;12(1):429–33.
28. Joglekar AP. Method Development and Validation for the Estimation of Telmisartan and Chlorthalidone in Bulk and Pharmaceutical Dosage Form by HPTLC Method. Res J Pharm Technol. 2015;8(4):376–81.
29. Parmar KA, Tandel FB, Rabari D. Analytical Method Development and Validation of Desloratadine Tablet. Res J Pharm Technol. 2015;8(6):693–6.
30. Tamilselvi N, Sruthi K, Arivukkarasu R, Vanathi P, Visakh D. Development of Validated HPTLC Method for Simultaneous Estimation of Fexofenadine Hydrochloride and Montelukast Sodium in Tablet Dosage Form. Res J Pharm Technol. 2016;9(4):469–73.