Author(s):
K. Radhika, Bitla Pravalika, Ramya Sri. S
Email(s):
radhikakspkg@gmail.com
DOI:
10.52711/2231-5713.2023.00029 
Address:
K. Radhika1*, Bitla Pravalika1, Ramya Sri. S2
1Department of Pharmaceutical Analysis, Samskruti College of Pharmacy, Affiliated to JNTUH University, Hyderabad 501301, Telangana, India.
2Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telangana, 500007, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 3,
Year - 2023
ABSTRACT:
Analytical Method Development and Validation for Spironolactone and Hydrochlorothiazide in bulk and Combined Dosage Form by RP-HPLC. New method was established for simultaneous estimation of Spironolactone and Hydrochlorothiazideby RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Spironolactone and Hydrochlorothiazideby using Inertsil C18 (4.6mm ×250mm, 5µm particle size), flow rate was 1.0ml/min, mobile phase ratio was (55:45% v/v) Methanol: Phosphate buffer pH 4.8 (pH was adjusted with ortho phosphoricacid), detection wavelength was 282nm. The instrument used was WATERS Alliance 2695 separation module, Software: Empower 2, 996 PDA detector. The retention times were found to be 1.688mins and 3.282mins. The %purity of Spironolactone and Hydrochlorothiazidewas found to be 99.86%. The system suitability parameters for Spironolactone and Hydrochlorothiazidesuch as theoretical plates and tailing factor were found to be 7586, 1.69 and 6235 and 1.58, the resolution were found to be 10.85. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study ofSpironolactone and Hydrochlorothiazidewas found in concentration range of 100µg-500µg and 30µg - 70µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.112% and 100.16%, %RSD for repeatability was 0.1702 and 0.043 respectively. The precision study was precise, robust, and repeatable. The LOD value was found to be 2.1µg/ml and 1.28µg/ml, and LOQ value was 6.3µg/ml and 3.84µg/ml for Spironolactone and Hydrochlorothiaziderespectively. Hence the suggested RP-HPLC method can be used for routine analysis of Spironolactone and Hydrochlorothiazide in API and Pharmaceutical dosage form.
Cite this article:
K. Radhika, Bitla Pravalika, Ramya Sri. S. Analytical Method Development and Validation for Estimation of Spironolactone and Hydrochlorothiazide in Bulk and Tablet Dosage form by High Performance Liquid Chromatography. Asian Journal of Pharmacy and Technology. 2023; 13(3):166-0. doi: 10.52711/2231-5713.2023.00029
Cite(Electronic):
K. Radhika, Bitla Pravalika, Ramya Sri. S. Analytical Method Development and Validation for Estimation of Spironolactone and Hydrochlorothiazide in Bulk and Tablet Dosage form by High Performance Liquid Chromatography. Asian Journal of Pharmacy and Technology. 2023; 13(3):166-0. doi: 10.52711/2231-5713.2023.00029 Available on: https://ajptonline.com/AbstractView.aspx?PID=2023-13-3-2
REFERENCES:
1. Vegesna Swetha, S. V. U. M. Prasad, Y. Asha Rani. Analytical method development and validation for simultaneous estimation of Cobicistat and Elvitegravir by using RP-HPLC in pure and Pharmaceutical Dosage Forms. Asian J. Pharm. Ana. 2017; 7(3): 151-158. doi: 10.5958/2231-5675.2017.00024.2
2. Rohini S. Koli, Aslam S. Patel, Kamlesh N. Chaudhari, Khushbu R. Patil. A Review on HPLC and Its New Trends. Asian J. Pharm. Ana. 2018; 8(4): 233-236. doi: 10.5958/2231-5675.2018.00042.X
3. Rohankumar R. Chavan, Sheela S. Thorat, Aishwarya R Thoke. Degradation Study of Spironolactone by UV- Visible Spectrophotometry Method in Bulk Form. Asian J. Pharm. Tech. 2019; 9(3):185-188. doi: 10.5958/2231-5713.2019.00031.X
4. Nilesh V. Gaikwad, Padmanabh B. Deshpande, Santosh V. Gandhi, Kapil K. Khandagale. High Performance Thin Layer Chromatographic Determination of Spironolactone and Torsemide in Combined Tablet Dosage Form. Research J. Pharm. and Tech.3 (4): Oct.-Dec.2010; Page 1106-1108.
5. https://go.drugbank.com/structures/DB00421/
6. Gandla Kumaraswamy, Gandla Lalitha, N. Ravindra, K.B. Pradeesha. Simultaneous Estimation of Amlodipine, Atenolol and Hydrochlorothiazide in Bulk and Tablet Dosage Form by RP-HPLC Method. Asian J. Pharm. Ana. 4(4): Oct. - Dec. 2014; Page 131-136.
7. Audumbar Digambar Mali. Simultaneous Determination of Carvedilol and Hydrochlorothiazide in Pharmaceutical Dosage Form by Second Order Derivative UV Spectrophotometry. Asian J. Pharm. Ana. 5(3): July- Sept. 2015; Page 133-138. doi: 10.5958/2231-5675.2015.00021.6
8. Bhadresh V. Savaj, Ashutosh Kumar Patidar, Hashumati A. Raj. Simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide in Tablets formulation using spectrophotometric technique (Simultaneous Equation Method). Asian J. Pharm. Ana. 5(1): Jan.- March 2014; Page 36-40. doi: 10.5958/2231-5675.2015.00007.1
9. Sridevi Ranjitha Karanam, V. Reena Jyothi Swarupa. Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form. Asian J. Pharm. Ana. 6(1): January- March, 2016; Page 7-14. doi: 10.5958/2231-5675.2016.00002.8
10. https://go.drugbank.com/structures/DB00999/
11. R. Anantha Kumar, G. Raveendra Babu, M. Sowjanya, M. Ramayyappa. Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):207-1. doi: 10.52711/2231-5675.2021.00037
12. Kushal Ramdas Landge, Suhas Siddheshwar, Rajashree Ghogare. Analytical Method Development and Validation of Ramipril and Hydrochlorothiazide- A Review. Research J. Science and Tech. 2020; 12(3):211-221. doi: 10.5958/2349-2988.2020.00029.7
13. M. Girija, N. Kokilavani. Effectiveness of Structured Teaching Programme on Knowledge, Attitude and Practice among Patients with Hypertension. Asian J. Nur. Edu. & Research 4(1): Jan.-March 2014; Page 136-139.
14. Devi. S, L N Samaga. Effect of transcendental meditation on stress and blood pressure among patients with systemic hypertension. Asian J. Nur. Edu. and Research 5(1): Jan.-March 2015; Page151-156. doi: 10.5958/2349-2996.2015.00032.4
15. Kavitha. T. A Study to Evaluate the Effectiveness of Structured Teaching Program on Modification of Daily Life Patterns Among Hypertensive Clients Attending OPD at Selected Hospital, Bangalore. Asian J. Nur. Edu. and Research 2016; 6(1): 93-95. doi: 10.5958/2349-2996.2016.00019.7
16. ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization, IFPMA, Geneva; 2005.
17. ICH Q2A. Text on Validation of Analytical Procedures, International Conference on Harmonization. Geneva; 1994.
18. ICH Q2A. Text on Validation of Analytical Procedures, International Conference on Harmonization. Geneva; 1995.
19. Sura, R. S., CVS, S., & rachamalla, S. S. (2022). Bioanalytical RP-HPLC Method Development And Validation Of Clopidogrel Bisulfate In Wistar Rat Plasma And Its Application To Pharmacokinetic Study. International Journal of Applied Pharmaceutics, 14(1), 106–111. https://doi.org/10.22159/ijap.2022v14i1.43328