V.L.N. Balaji Gupta Tiruveedhi, Venkateswara Rao Battula, Kishore Babu Bonige
V.L.N. Balaji Gupta Tiruveedhi1,2*, Venkateswara Rao Battula2, Kishore Babu Bonige2
1Department of Basic Science, Vishnu Institute of Technology (A), Bhimavaram, Andhra Pradesh, India.
2Department of Engineering Chemistry, Andhra University, Visakhapatnam, Andhra Pradesh, India.
Volume - 14,
Issue - 10,
Year - 2021
This research work was designed to establish and validate a novel stability indicating RP-HPLC method for the combined determination of Benidipine hydrochloride (BHE) and Nebivolol hydrochloride (NHE) in bulk and tablets, dependent on ICH guidelines.The assay method to analyse BHE and NHE was optimized with isocratic elution using acetonitrile: 0.1M acetate buffer (45:55, pH 5.1), Lichrospher ODS RP-18 column and flow pace of 1 ml/min. Total time for single run was 14 min. The injection quantity was 20µl, and was detected at 249nm. The method was verified on a concentration series of 1.25-10µg/ml (NHE) and 1.0-10µg/ml (BHE) for precision, accuracy and linearity. The LOD values were 0.059µg/ml and 0.028µg/ml for NHE and BHE, respectively. The LOQ values were 0.196µg/ml for NHE and 0.094µg/ml for BHE. The recovery percentages were 98.60-100.11% (BHE) and 98.94-101.50% (NHE) with relative standard deviation 0.250-0.694% (BHE) and 0.183-0.400% (NHE). The method was also observed to be efficient, and was sufficiently specific to measure BHE and NHE in the presence of stress-produced degradation products.
Cite this article:
V.L.N. Balaji Gupta Tiruveedhi, Venkateswara Rao Battula, Kishore Babu Bonige. Novel Determination of Anti-Hypertensive Combination; Benidipine Hydrochloride and Nebivolol Hydrochloride by High Performance Chromatographic Method. Research Journal of Pharmacy and Technology 2021; 14(10):5433-5438. doi: 10.52711/0974-360X.2021.00947
V.L.N. Balaji Gupta Tiruveedhi, Venkateswara Rao Battula, Kishore Babu Bonige. Novel Determination of Anti-Hypertensive Combination; Benidipine Hydrochloride and Nebivolol Hydrochloride by High Performance Chromatographic Method. Research Journal of Pharmacy and Technology 2021; 14(10):5433-5438. doi: 10.52711/0974-360X.2021.00947 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-10-65
1. Oparil S, Acelajado MC, Bakris GL, Berlowitz DR, Cífková R, Dominiczak AF, Grassi G, Jordan J, Poulter NR, Rodgers A, Whelton PK. Hypertension. Nature Reviews Disease Primers, 2018; 4: 18014.
2. Bolívar JJ. Essential hypertension: an approach to its etiology and neurogenic pathophysiology. International journal of Hypertension, 2013; 2013: 547809.
3. Zhou B, Bentham J, Di Cesare M, et al., NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19•1 million participants. Lancet, 2017; 389 (10064): 37-55.
4. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet, 2005; 365 (9455): 217-223.
5. Benidipine Nebivolol Hcl tablets, exportersindia.com, Accessed on May 2020, Available at: https://www.exportersindia.com/niksan-healthcare/benidipine-nebivolol-hcl-tablets-5123161.htm
6. Seino H, Miyaguchi S, Yamazaki T, Ota S, Yabe R, Suzuki S. Effect of benidipine hydrochloride, a long-acting T-type calcium channel blocker, on blood pressure and renal function in hypertensive patients with diabetes mellitus. Analysis after switching from cilnidipine to benidipine. ArzneimittelForschung, 2007; 57 (8): 526-531.
7. Yamamoto E, Kataoka K, Dong YF, Nakamura T, Fukuda M, Nako H, Ogawa H, Kim-Mitsuyama S. Benidipine, a dihydropyridine L-type/T-type calcium channel blocker, affords additive benefits for prevention of cardiorenal injury in hypertensive rats. Journal of Hypertension, 2010; 28 (6):1321-1329.
8. Tomino Y. Renoprotective effects of the L-/T-type calcium channel blocker benidipine in patients with hypertension. Current Hypertension Reviews, 2013; 9 (2): 108-114.
9. Fongemie J, Felix-Getzik E. A Review of nebivolol pharmacology and clinical evidence. Drugs, 2015; 75 (12): 1349‐1371.
10. Cicero AFG, Kuwabara M, Borghi C. A critical review of nebivolol and its fixed-dose combinations in the treatment of hypertension. Drugs, 2018; 78 (17): 1783-1790.
11. Ong HT, Ong LM, Kow FP. Beta-blockers for heart failure: an evidence-based review answering practical therapeutic questions. Medical Journal of Malaysia, 2012; 67 (1): 7-11.
12. Vijay SJ, Jitendra SS, Ashish KS, Santosh KS. Effect of dimethyl sulphoxides as permeation enhancer on transdermal patch of nebivolol hydrochloride. Asian Journal of Research in Pharmaceutical Sciences, 2013; 3 (1): 08-11.
13. Syed SA, Mohamed K, Nirmal TH, Syed SM. Colorimetric estimation of nebivolol hydrochloride in bulk and pharmaceutical dosage form. Asian Journal of Pharmacy and Technology, 2019; 9 (4): 253-259.
14. Rajanikant MC, Bhavin PM, Shailesh AS, Girish CD. First order derivative spectrophotometric method for simultaneous estimation of nebivolol hydrochloride and indapamide in tablet dosage form. Asian Journal of Research in Chemistry, 2012; 5 (2): 282-285.
15. International conference on the harmonization. ICH harmonized tripartite guideline. Validation of analytical procedures: Text and methodology Q2(R1); 2005.
16. International conference on the harmonization. ICH Stability testing of new drug substances and products Q1A (R2); 2003.
17. Sridevi RK, Swarupa VRJ. Stability indicating analytical method development and validation for simultaneous estimation of valsartan and hydrochlorothiazide in tablet dosage form. Asian Journal of Pharmaceutical Analysis, 2016; 6 (1): 7-14.
18. Chandana OSS, Babu RR. Stability indicating HPLC method development and validation for thalidomide and its impurity determination. Asian Journal of Pharmaceutical Analysis, 2016; 6(2): 115-118.
19. Sushil DP, Sunil VA, Upasani CD. Development and validation of stability indicating RP-HPLC method for empagliflozin. Asian Journal of Pharmaceutical Analysis, 2016; 6 (4): 201-206.
20. Vanita PR, Madhukar RT. A validated stability-indicating high-performance thin-layer chromatographic method for the analysis of pitavastatin in bulk drug and tablet fomulation. Asian Journal of Pharmaceutical Analysis, 2018; 8 (1): 49-52.
21. Mohite MT, Dudhabale VV, Chandgude KV. Validation of stability indicating RP-HPLC, method of analysis for assay of ivabradine HCl in SR tablet. Asian Journal of Pharmaceutical Analysis, 2019; 9 (3):133-137.
22. Jinal NT, Radhika VB, Nilam MP, Samir KS. Practical implication of stability indicating chromatographic method for estimation of clomipramine hydrochloride and its related substances from capsule dosage form. Asian Journal of Pharmaceutical Analysis, 2017; 7 (2): 100-112.
23. Parag AP, Vinod AB, Yogesh SA, Bhaskar OA. Development and validation of stability indicating UV spectrophotometric method for estimation of teneligliptine in bulk and tablet dosage form. Asian Journal of Pharmaceutical Analysis, 2019; 9 (3): 128-132.