Research Article
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Year 2025, Volume: 29 Issue: 3, 1284 - 1294, 04.06.2025
https://doi.org/10.12991/jrespharm.1710280
https://izlik.org/JA26GG79BR

Abstract

References

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  • [2] Mateti A, Aarelly K, Thimmaraju MK, Raghunandan N. Method development and validation of nicardipine hydrochloride in bulk and formulation using UV spectrophotometric method. J Chem Pharm Res. 2012;4(7):3688-3694.
  • [3] Lotfy HM, Hegazy MAE, Abd El-Aziz MM, Abdel Fattah LE. Stability indicating spectrophotometric methods for determination of nicardipine in the presence of its alkaline induced degradation products. Int J Pharm Pharm Sci. https://journals.innovareacademics.in/index.php/ijpps/article/view/8603/4819
  • [4] Derayea SM, Askal HF, Abdel-Megeed OH, El Hamd MA. Spectrophotometric determination of amlodipine and nicardipine in pharmaceutical formulations via binary complex formation with eosin Y. J Appl Pharm Sci. 2012; 2(6). http://dx.doi.org/10.7324/JAPS.2012.2622
  • [5] Chintamaneni PK, Nagasen D, Babu KC, Mourya A, Madan J, Srinivasarao DA, Rama Chandra RK,Madhuri Santosji P.Sai kiran P Engineered upconversion nanocarriers for synergistic breast cancer imaging and therapy: Current state of art. J Control Release. 2022;352:652-672. http://dx.doi.org/10.1016/j.jconrel.2022.10.056
  • [6] Qi M, Wang P, Jin X. Liquid chromatography–mass spectrometry method for the determination of nicardipine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 ;830(1):81-85. https://doi.org/10.1016/j.jchromb.2005.10.035.
  • [7] Pindiprolu SK, Madhan J, Srinivasarao DA, Kumar CS, Dasari N, Phani kumar Ch.S, Jyothi VG. Therapeutic targeting of aberrant sialylation for prevention of chemoresistance and metastasis in triple negative breast cancer. J Drug Deliv Sci Technol. 2023;104617. http://dx.doi.org/10.1016/j.jddst.2023.104617
  • [8] Kasture VS, Pawar SS, Musmade DS, Patil PP, Gaware SR. Synthesis, characterization and development of validated RP-HPLC method for the estimation of process-related impurities in nicardipine formulation. Indo Am J Pharm Res. 2013; 4. http://www.scopemed.org/?mno=152447.
  • [9] Aminabee S, Dasari SK, Rao KH, Sirisha V, Anitha Kumari V, Dasari N, Sujiva B, Leelaavati TS. Pharmacoeconomic analysis of biologic vs. biosimilar therapies in rheumatoid arthritis. Int J Chem Biochem Sci. 2023;24(4):395-400.
  • [10] Teraoka R, Otsuka M, Matsuda Y. Evaluation of photostability of solid-state nicardipine hydrochloride polymorphs by using Fourier-transformed reflection–absorption infrared spectroscopy – effect of grinding on the photostability of crystal form. Int J Pharm. 2004;286(1-2):1-8. http://dx.doi.org/10.1016/j.ijpharm.2004.07.026
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  • [12] Rao SS, Vaghela BK. Identification and characterization of a novel potential degradant and development and validation of stability-indicating RP-LC method for nicardipine impurities in injectable dosage form. J Liq Chromatogr Relat Technol.2013;36(15): 2166-2181. http://dx.doi.org/10.1080/10826076.2012.717056
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  • [17] Walash MI, Belal F, El-Enany N, Abdelal A. Microemulsion liquid chromatographic determination of nicardipine hydrochloride in pharmaceutical preparations and biological fluids. Application to stability studies. J Liq Chromatogr Relat Technol. 2007; 30(8):1015-1034.http://dx.doi.org/10.1080/10826070601128394
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  • [21] Avula PR, Chettupalli AK, Chauhan V, Jadi RK. Design, formulation, in-vitro and in-vivo pharmacokinetic evaluation of nicardipine-nanostructured lipid carrier for transdermal drug delivery system. Mater Today Proc. 2023;48:1673-1678. https://doi.org/10.1016/j.matpr.2023.06.282
  • [22] Krishnaiah YSR, Satyanarayana V, Bhaskar P. High performance liquid chromatographic determination of nicardipine hydrochloride in human plasma. E-J Chem. 2004;1(1):38-42. https://doi.org/10.1155/2004/542981
  • [23] Vamsikrishna P, Malyadri T, Saibabu C. Formulation development and in vitro evaluation of bilayer tablets nicardipine. World J Curr Med Pharm Res.2021; 3(3):40-49. https://doi.org/10.37022/wjcmpr.vi.172.
  • [24] Miskan R, Shahidulla SM, Sultana S. Revolutionizing drug delivery: Nicardipine nanosuspension formulation and in-vitro evaluation. J Drug Deliv Ther. 2023;13(12):134-134. https://doi.org/10.22270/jddt.v13i12.6134
  • [25] Roy H, Chakraborty A, Nayak BS, Bhanja S, Mishra SR, Ellaiah P. Design and in vitro evaluation of sustained release matrix tablets of complexed nicardipine hydrochloride. Int J Pharm Pharm Sci. 2010;2(4):128-132.
  • [26] Rajesh D, Akruti K, Oza NA. Bioavailability study of developed S-SMEDDS formulation for nicardipine hydrochloride in rats. Res J Pharm Technol. 2022;15(5). https://doi.org/10.52711/0974-360X.2022.00422
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  • [30] Mohanty C, Subrahmanyam KV, Mohammad AS, Jena TK. Thermal sintering technique: A novel strategy used in the design of gastro retentive floating matrix tablets of nicardipine HCl and its evaluation. Int J Pharma Res Health Sci. 2016; 4(1): 1004-1009.
  • [31] Dumpala RL, Khodakiya A. Formulation and statistical optimization of S-SMEDDS of nicardipine hydrochloride by using BBD and PCA design. Int J Pharm Sci Res.2021; 12(3):1860-1874. https://doi,org/ 10.13040/IJPSR.0975-8232.12(3).1860-74
  • [32] Yuksel N, Dinc E, Onur F, Baykara T. Influence of swelling degree on release of nicardipine hydrochloride from acrylic microspheres prepared by solvent evaporation method. Pharm Dev Technol.1998;3(2):https://doi.org/ 10.3109/10837459809028485
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  • [34] Zlomke C, Albrecht J, Mader K. Nicardipine loaded solid phospholipid extrudates for the prevention of cerebral vasospasms: In vitro characterization. Pharmaceutics. 2020;12(9):817. https://doi.org/10.3390/pharmaceutics12090817
  • [35] Krishnaiah YSR, Satyanarayana V, Karthikeyan RS. Enhanced percutaneous permeability of nicardipine hydrochloride by carvone across the rat abdominal skin. Drug Dev Ind Pharm. 2003;101-109.https://doi.org/10.1080/713840367
  • [36] Takka S, Ocak OH, Acarturk F. Formulation and investigation of nicardipine HCl.alginate gel beads with factorial design-based studies. Eur J Pharm Sci. 1998;6(3):241-246. https://doi.org/10.1016/S0928-0987(97)10005-7
  • [37] Yanez C, Squilla A. Differential pulse polarographic and UV-Vis spectrophotometric study of inclusion complexes formed by 1,4-dihydropyridine calcium antagonists, nifedipine and nicardipine with ƒÀ-cyclodextrin. Electroanalysis. 2003; 15: 1771-1777. https://doi.org/10.1002/elan.200302720
  • [38] Soomherun N, Kreua-ongarjnukool N, Niyomthai ST, Chumnanvej S. Kinetics of drug release via nicardipine hydrochloride-loaded carboxymethyl cellulose/poly (D, L-lactic-co-glycolic acid) nanocarriers using a contemporary emulsion process. ChemNanoMat. 2020; 6:1754. https://doi.org/10.1002/cnma.202000528.
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Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form

Year 2025, Volume: 29 Issue: 3, 1284 - 1294, 04.06.2025
https://doi.org/10.12991/jrespharm.1710280
https://izlik.org/JA26GG79BR

Abstract

Nicardipine HCl as Monotherapy or in combination therapy for treating severe Angina and high blood pressure. Its mechanism involves the relaxation of blood vessels, thereby reducing the workload on the heart and lowering blood pressure. İt reduces myocardial oxygen demand by reducing after load and increasing myocardial oxygen supply through coronary vaso dilation. İn present study the solubility and release of the Nicardipine HCl in various solvents was examined based on solubility studies and the choice of solvent was determined by considering its solubility properties. Nicardipine HCl by comparison method. Nicardipine HCl is used to treat Angina, hypertension, arterial relaxation, vasodilation and so on. Currently Nicardipine HCl is marketed in different Novel drug formulations such as Nanoparticles, Capsules, Niosomes, Hydrogels for reducing blood pressure and many analytical techniques were used like HPLC, GC and GC-MS, LC-MS for carrying out the various quantitative and qualitative analyses are some examples of these developments. In this study, Nicardipine HCl was treated with various solvents like Methanol, Phosphate Buffers of PH 3.6 and 6.8. A method was developed and validated with validation parameters like Linearity, Accuracy, Precision, Specificity, LOQ, LOD etc., by using UV-Visible Spectroscopy. Results of the study revealed that Nicardipine HCl gives data about the Linearity, precision, accuracy of Nicardipine HCl gives Linearity 15-55μg/ml, Regression 0.998, LOD, LOQ. By carefully selecting suitable solvents, we successfully established a reliable and efficient method for determining and estimation of Nicardipine HCl by using Spectrophotometric method. Method was developed, optimized and Validated with its parameters

References

  • [1] Dasari N, Balla S, Kondrapu PR, Gummadi R, Surada NR, Kondru UM, Dai kiran P. Targeting angiogenesis with fluphenazine-zinc oxide nanoconjugates: A potential mechanism for improving antipsychotic efficacy. Int J Appl Pharm. 2023;15(5). http://dx.doi.org/10.22159/ijap.2023v15i5.48317
  • [2] Mateti A, Aarelly K, Thimmaraju MK, Raghunandan N. Method development and validation of nicardipine hydrochloride in bulk and formulation using UV spectrophotometric method. J Chem Pharm Res. 2012;4(7):3688-3694.
  • [3] Lotfy HM, Hegazy MAE, Abd El-Aziz MM, Abdel Fattah LE. Stability indicating spectrophotometric methods for determination of nicardipine in the presence of its alkaline induced degradation products. Int J Pharm Pharm Sci. https://journals.innovareacademics.in/index.php/ijpps/article/view/8603/4819
  • [4] Derayea SM, Askal HF, Abdel-Megeed OH, El Hamd MA. Spectrophotometric determination of amlodipine and nicardipine in pharmaceutical formulations via binary complex formation with eosin Y. J Appl Pharm Sci. 2012; 2(6). http://dx.doi.org/10.7324/JAPS.2012.2622
  • [5] Chintamaneni PK, Nagasen D, Babu KC, Mourya A, Madan J, Srinivasarao DA, Rama Chandra RK,Madhuri Santosji P.Sai kiran P Engineered upconversion nanocarriers for synergistic breast cancer imaging and therapy: Current state of art. J Control Release. 2022;352:652-672. http://dx.doi.org/10.1016/j.jconrel.2022.10.056
  • [6] Qi M, Wang P, Jin X. Liquid chromatography–mass spectrometry method for the determination of nicardipine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 ;830(1):81-85. https://doi.org/10.1016/j.jchromb.2005.10.035.
  • [7] Pindiprolu SK, Madhan J, Srinivasarao DA, Kumar CS, Dasari N, Phani kumar Ch.S, Jyothi VG. Therapeutic targeting of aberrant sialylation for prevention of chemoresistance and metastasis in triple negative breast cancer. J Drug Deliv Sci Technol. 2023;104617. http://dx.doi.org/10.1016/j.jddst.2023.104617
  • [8] Kasture VS, Pawar SS, Musmade DS, Patil PP, Gaware SR. Synthesis, characterization and development of validated RP-HPLC method for the estimation of process-related impurities in nicardipine formulation. Indo Am J Pharm Res. 2013; 4. http://www.scopemed.org/?mno=152447.
  • [9] Aminabee S, Dasari SK, Rao KH, Sirisha V, Anitha Kumari V, Dasari N, Sujiva B, Leelaavati TS. Pharmacoeconomic analysis of biologic vs. biosimilar therapies in rheumatoid arthritis. Int J Chem Biochem Sci. 2023;24(4):395-400.
  • [10] Teraoka R, Otsuka M, Matsuda Y. Evaluation of photostability of solid-state nicardipine hydrochloride polymorphs by using Fourier-transformed reflection–absorption infrared spectroscopy – effect of grinding on the photostability of crystal form. Int J Pharm. 2004;286(1-2):1-8. http://dx.doi.org/10.1016/j.ijpharm.2004.07.026
  • [11] Dasari N, Guntuku GS, Pindiprolu SKSS. Targeting triple negative breast cancer stem cells using nanocarriers. Discover Nano. 2024;19:41. http://dx.doi.org/10.1186/s11671-024-03985-y
  • [12] Rao SS, Vaghela BK. Identification and characterization of a novel potential degradant and development and validation of stability-indicating RP-LC method for nicardipine impurities in injectable dosage form. J Liq Chromatogr Relat Technol.2013;36(15): 2166-2181. http://dx.doi.org/10.1080/10826076.2012.717056
  • [13] Rahman N, Azmi SNH. Validated spectrophotometric method for the assay of nifedipine in bulk and commercial dosage forms. SciAsia. 2006;32:429-435. http://dx.doi.org/10.2306/scienceasia1513-1874.2006.32.429
  • [14] Al-Ghannam SM, Al-Olyan AM. Spectrofluorometric determination of nicardipine, nifedipine and isradipine in pharmaceutical preparations and biological fluids. Cent Eur J Chem.2008;6(2):222-229. http://dx.doi.org/10.2478/s11532-008-0011-x
  • [15] Dasari N, Kumar CSP, Gummadi RK, Pindiprolu SKSS, Balla S, Masa A. Application of novel natural sweetening agent-stevia in formulation, evaluation of nicardipine hydrochloride orodispersable for rapid absorption. Indian J Pharm Educ Res. 2024;58(1s):17. http://dx.doi.org/10.5530/ijper.58.1s.17
  • [16] El Hamd MA, Abdellatif AAH, Derayea SM, Abdelmageed OH, Askal HF. Spectrophotometric determination of nifedipine and nicardipine in their pharmaceutical preparations. Ind Chem Open Access. http://dx.doi.org/10.4172/ico.1000103
  • [17] Walash MI, Belal F, El-Enany N, Abdelal A. Microemulsion liquid chromatographic determination of nicardipine hydrochloride in pharmaceutical preparations and biological fluids. Application to stability studies. J Liq Chromatogr Relat Technol. 2007; 30(8):1015-1034.http://dx.doi.org/10.1080/10826070601128394
  • [18] Bonferoni MC, Mellerio G, Giunchedi P, Caramella C, Conte U. Photostability evaluation of nicardipine HCl solutions. Int J Pharm.1992;80(3):109-117. https://doi.org/10.1016/0378-5173(92)90268-7
  • [19] Al-Ghannam SM, Al-Olayan AM. Stability-indicating HPLC method for the determination of nicardipine in capsules and spiked human plasma. Identification of degradation products using HPLC/MS. Arab J Chem.2019;12(8):1983-1993. https://doi.org/10.1016/j.arabjc.2014.11.044
  • [20] Ibrahim KE, Al-Ashban RM, Babiker LB. A selective high performance liquid chromatographic method to follow the hydrolytic degradation of nicardipine hydrochloride. E-J Chem. 2010;7(1):85-92. https://doi.org/10.1155/2010/542981
  • [21] Avula PR, Chettupalli AK, Chauhan V, Jadi RK. Design, formulation, in-vitro and in-vivo pharmacokinetic evaluation of nicardipine-nanostructured lipid carrier for transdermal drug delivery system. Mater Today Proc. 2023;48:1673-1678. https://doi.org/10.1016/j.matpr.2023.06.282
  • [22] Krishnaiah YSR, Satyanarayana V, Bhaskar P. High performance liquid chromatographic determination of nicardipine hydrochloride in human plasma. E-J Chem. 2004;1(1):38-42. https://doi.org/10.1155/2004/542981
  • [23] Vamsikrishna P, Malyadri T, Saibabu C. Formulation development and in vitro evaluation of bilayer tablets nicardipine. World J Curr Med Pharm Res.2021; 3(3):40-49. https://doi.org/10.37022/wjcmpr.vi.172.
  • [24] Miskan R, Shahidulla SM, Sultana S. Revolutionizing drug delivery: Nicardipine nanosuspension formulation and in-vitro evaluation. J Drug Deliv Ther. 2023;13(12):134-134. https://doi.org/10.22270/jddt.v13i12.6134
  • [25] Roy H, Chakraborty A, Nayak BS, Bhanja S, Mishra SR, Ellaiah P. Design and in vitro evaluation of sustained release matrix tablets of complexed nicardipine hydrochloride. Int J Pharm Pharm Sci. 2010;2(4):128-132.
  • [26] Rajesh D, Akruti K, Oza NA. Bioavailability study of developed S-SMEDDS formulation for nicardipine hydrochloride in rats. Res J Pharm Technol. 2022;15(5). https://doi.org/10.52711/0974-360X.2022.00422
  • [27] Fuss D, Gonde H, Lamoureux F, Pereira T. Stability study of a compounded oral solution of nicardipine for the treatment of hypertension in children. Eur J Pharm Sci. 2021;105738. https://doi.org/10.1016/j.ejps.2021.105738
  • [28] Cavelier M, Gonde H, Costa D, Lamoureux F, Pereira T, Buchbinder N, et al. Development of an oral liquid formulation of nicardipine hydrochloride compounded with simple excipients for the treatment of pediatric hypertension. Pharmaceutics. 2023;15:446. https://doi.org/10.3390/pharmaceutics15020446
  • [29] Aher S, Saudagar R, Shinde M. Formulation and evaluation of fast dissolving tablet of nicardipine hydrochloride by using solid dispersion technique. Pharma Innov J. 2018;7(8):146-155.
  • [30] Mohanty C, Subrahmanyam KV, Mohammad AS, Jena TK. Thermal sintering technique: A novel strategy used in the design of gastro retentive floating matrix tablets of nicardipine HCl and its evaluation. Int J Pharma Res Health Sci. 2016; 4(1): 1004-1009.
  • [31] Dumpala RL, Khodakiya A. Formulation and statistical optimization of S-SMEDDS of nicardipine hydrochloride by using BBD and PCA design. Int J Pharm Sci Res.2021; 12(3):1860-1874. https://doi,org/ 10.13040/IJPSR.0975-8232.12(3).1860-74
  • [32] Yuksel N, Dinc E, Onur F, Baykara T. Influence of swelling degree on release of nicardipine hydrochloride from acrylic microspheres prepared by solvent evaporation method. Pharm Dev Technol.1998;3(2):https://doi.org/ 10.3109/10837459809028485
  • [33] Al-Zeina H, Sakeer K, Alanazi FK. Designing an extended release waxy matrix tablet containing nicardipine.hydroxy propyl b cyclodextrin complex. Saudi Pharm J. 2011;19(4):245-53. htpps://doi.org/ 10.1016/j.jsps.2011.05.004.
  • [34] Zlomke C, Albrecht J, Mader K. Nicardipine loaded solid phospholipid extrudates for the prevention of cerebral vasospasms: In vitro characterization. Pharmaceutics. 2020;12(9):817. https://doi.org/10.3390/pharmaceutics12090817
  • [35] Krishnaiah YSR, Satyanarayana V, Karthikeyan RS. Enhanced percutaneous permeability of nicardipine hydrochloride by carvone across the rat abdominal skin. Drug Dev Ind Pharm. 2003;101-109.https://doi.org/10.1080/713840367
  • [36] Takka S, Ocak OH, Acarturk F. Formulation and investigation of nicardipine HCl.alginate gel beads with factorial design-based studies. Eur J Pharm Sci. 1998;6(3):241-246. https://doi.org/10.1016/S0928-0987(97)10005-7
  • [37] Yanez C, Squilla A. Differential pulse polarographic and UV-Vis spectrophotometric study of inclusion complexes formed by 1,4-dihydropyridine calcium antagonists, nifedipine and nicardipine with ƒÀ-cyclodextrin. Electroanalysis. 2003; 15: 1771-1777. https://doi.org/10.1002/elan.200302720
  • [38] Soomherun N, Kreua-ongarjnukool N, Niyomthai ST, Chumnanvej S. Kinetics of drug release via nicardipine hydrochloride-loaded carboxymethyl cellulose/poly (D, L-lactic-co-glycolic acid) nanocarriers using a contemporary emulsion process. ChemNanoMat. 2020; 6:1754. https://doi.org/10.1002/cnma.202000528.
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There are 49 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences (Other)
Journal Section Research Article
Authors

Nagasen Dasari This is me

Sujiya Balla This is me

Sharon Priyanka Palina This is me

Sathis Kumar Dinakaran This is me

Rama Krishna Gummadi This is me

Submission Date June 1, 2024
Acceptance Date July 22, 2024
Publication Date June 4, 2025
DOI https://doi.org/10.12991/jrespharm.1710280
IZ https://izlik.org/JA26GG79BR
Published in Issue Year 2025 Volume: 29 Issue: 3

Cite

APA Dasari, N., Balla, S., Palina, S. P., Dinakaran, S. K., & Gummadi, R. K. (2025). Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form. Journal of Research in Pharmacy, 29(3), 1284-1294. https://doi.org/10.12991/jrespharm.1710280
AMA 1.Dasari N, Balla S, Palina SP, Dinakaran SK, Gummadi RK. Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form. J. Res. Pharm. 2025;29(3):1284-1294. doi:10.12991/jrespharm.1710280
Chicago Dasari, Nagasen, Sujiya Balla, Sharon Priyanka Palina, Sathis Kumar Dinakaran, and Rama Krishna Gummadi. 2025. “Novel UV-Visible Spectroscopy Method for Development and Validation of Nicardipine Hydrochloride in Bulk Form”. Journal of Research in Pharmacy 29 (3): 1284-94. https://doi.org/10.12991/jrespharm.1710280.
EndNote Dasari N, Balla S, Palina SP, Dinakaran SK, Gummadi RK (June 1, 2025) Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form. Journal of Research in Pharmacy 29 3 1284–1294.
IEEE [1]N. Dasari, S. Balla, S. P. Palina, S. K. Dinakaran, and R. K. Gummadi, “Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form”, J. Res. Pharm., vol. 29, no. 3, pp. 1284–1294, June 2025, doi: 10.12991/jrespharm.1710280.
ISNAD Dasari, Nagasen - Balla, Sujiya - Palina, Sharon Priyanka - Dinakaran, Sathis Kumar - Gummadi, Rama Krishna. “Novel UV-Visible Spectroscopy Method for Development and Validation of Nicardipine Hydrochloride in Bulk Form”. Journal of Research in Pharmacy 29/3 (June 1, 2025): 1284-1294. https://doi.org/10.12991/jrespharm.1710280.
JAMA 1.Dasari N, Balla S, Palina SP, Dinakaran SK, Gummadi RK. Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form. J. Res. Pharm. 2025;29:1284–1294.
MLA Dasari, Nagasen, et al. “Novel UV-Visible Spectroscopy Method for Development and Validation of Nicardipine Hydrochloride in Bulk Form”. Journal of Research in Pharmacy, vol. 29, no. 3, June 2025, pp. 1284-9, doi:10.12991/jrespharm.1710280.
Vancouver 1.Dasari N, Balla S, Palina SP, Dinakaran SK, Gummadi RK. Novel UV-Visible Spectroscopy method for development and validation of nicardipine hydrochloride in bulk form. J. Res. Pharm. [Internet]. 2025 June 1;29(3):1284-9. Available from: https://izlik.org/JA26GG79BR