Author(s):
Sahil S. Naik, Kishori P. Sutar, Anvitha W. Sequeira, Arun D. Jadhav, Shourya J. Jadhav
Email(s):
kishorisutar@klepharm.edu
DOI:
10.52711/0974-360X.2025.00356 
Address:
Sahil S. Naik, Kishori P. Sutar*, Anvitha W. Sequeira, Arun D. Jadhav, Shourya J. Jadhav
Department of Pharmaceutics, KLE College of Pharmacy, Belagavi.
KLE Academy Higher Education and Research, Nehru Nagar, Belagavi - 590010, Karnataka, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 6,
Year - 2025
ABSTRACT:
Purpose: The study aims to present a swift, precise, and sensitive UV-spectrophotometric technique for assessing AKBA in bulk and nanoformulations. Method: The ideal conditions for AKBA analysis was developed using methanol and water in 1:1 ratio. It shows maximum absorbance at 255nm wavelength. Several validation criteria’s such as precision, LOD, LOQ, accuracy, robustness, and ruggedness were estimated with the QC norms in accordance with the ICH Q2 (R1) guidelines. The validated method was used in quantifying AKBA in bulk and nanoformulations. Result: AKBA exhibited a maximum absorption wavelength at 255nm. The linear equation y = 0.012x+0.0196 was established, demonstrating a linear response within the concentration range of 20-60µg/mL with a regression coefficient of 0.995. The limit of detection and limit of quantification were found to be 3.297 and 9.992µg/mL, respectively. The precision and repeatability values were within 2% acceptance range. Following ICH guidelines, the method underwent comprehensive validation for linearity, ruggedness, precision, specificity, and sensitivity, meeting acceptable criteria. Conclusion: Therefore, as per the results, it can be concluded that the developed method is deemed new, simple, consistent, and accurate, suitable for routine quality control in the pharmaceutical industry for raw materials and formulations. 3-acetyl-11-keto-beta-Boswellic acid (AKBA), UV-Spectrophotometric, Nanoformulation, Method development, Estimation.
Cite this article:
Sahil S. Naik, Kishori P. Sutar, Anvitha W. Sequeira, Arun D. Jadhav, Shourya J. Jadhav. UV- Method Development for Quantifying 3-Acetyl-11-Keto-Beta-Boswellic Acid in Bulk and Topical Nanoformulation.Research Journal of Pharmacy and Technology. 2025;18(6):2493-0. doi: 10.52711/0974-360X.2025.00356
Cite(Electronic):
Sahil S. Naik, Kishori P. Sutar, Anvitha W. Sequeira, Arun D. Jadhav, Shourya J. Jadhav. UV- Method Development for Quantifying 3-Acetyl-11-Keto-Beta-Boswellic Acid in Bulk and Topical Nanoformulation.Research Journal of Pharmacy and Technology. 2025;18(6):2493-0. doi: 10.52711/0974-360X.2025.00356 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-6-9
REFERENCES:
1. Yang Y, Li Z, Huang P, Lin J, Li J, Shi K, Lin J, Hu J, Zhao Z, Yu Y, Chen H. Rapidly separating dissolving microneedles with sustained-release colchicine and stabilized uricase for simplified long-term gout management. Acta Pharmaceutica Sinica B. 2023; 13(8): 3454-70. https://doi.org/10.1016/j.apsb.2023.02.011
2. Yadav S, Bhosale M, Sattigeri B, Vimal S. Pharmacological overview for therapy of gout and hyperuricemia. International Journal of Health Sciences. 2022: 7772-85. https://doi.org/10.53730/ijhs.v6nS2.6926
3. Mehta M, Dureja H, Garg M. Development and optimization of boswellic acid-loaded proniosomal gel. Drug delivery. 2016; 23(8): 3072-81. https://doi.org/10.3109/10717544.2016.1149744
4. Sabina EP, Indu H, Rasool M. Efficacy of boswellic acid on lysosomal acid hydrolases, lipid peroxidation and anti–oxidant status in gouty arthritic mice. Asian Pacific Journal of Tropical Biomedicine. 2012; 2(2): 128-33. doi: 10.1016/S2221-1691(11)60206-2
5. Goel A, Ahmad FJ, Singh RM, Singh GN. 3-Acetyl-11-keto-β-boswellic acid loaded-polymeric nanomicelles for topical anti-inflammatory and anti-arthritic activity. Journal of Pharmacy and Pharmacology. 2010; 62(2): 273-8. DOI 10.1211/jpp/62.02.0016
6. Javed S, Mangla B, Almoshari Y, Sultan MH, Ahsan W. Nanostructured lipid carrier system: A compendium of their formulation development approaches, optimization strategies by quality by design, and recent applications in drug delivery. Nanotechnology Reviews. 2022; 11(1): 1744-77. https://doi.org/10.1515/ntrev-2022-0109
7. Shah SA, Rathod IS, Suhagia BN, Patel DA, Parmar VK, Shah BK, Vaishnavi VM. Estimation of boswellic acids from market formulations of Boswellia serrata extract and 11-keto β-boswellic acid in human plasma by high-performance thin-layer chromatography. Journal of Chromatography B. 2007; 848(2): 232-8. https://doi.org/10.1016/j.jchromb.2006.10.026
8. Katragunta K, Siva B, Kondepudi N, Vadaparthi PR, Rao NR, Tiwari AK, Babu KS. Estimation of boswellic acids in herbal formulations containing Boswellia serrata extract and comprehensive characterization of secondary metabolites using UPLC-Q-Tof-MSe. Journal of Pharmaceutical Analysis. 2019; 9(6): 414-22. https://doi.org/10.1016/j.jpha.2019.09.007
9. Katragunta K, Siva B, Kondepudi N, Vadaparthi PR, Rao NR, Tiwari AK, Babu KS. Estimation of boswellic acids in herbal formulations containing Boswellia serrata extract and comprehensive characterization of secondary metabolites using UPLC-Q-Tof-MSe. Journal of Pharmaceutical Analysis. 2019; 9(6): 414-22. https://doi.org/10.1016/j.jpha.2019.09.007
10. Shinde GS, Jadhav RS, Tambe VB, Kote RB, Argade VP. Bioanalytical Method Development and Validation of UV Spectrophotometric Method for Estimation of Sitagliptin in Urine sample. Research Journal of Science and Technology. 2024; 16(1): 19-23. DOI : 10.52711/2349-2988.2024.00004
11. Rathod RD, Nangare SN, Patil VR, Rathod HS, Shitole MM, Tade RS. Zero-order derivative and area under curve uv-spectrophotometric methods for determination of calcium levofolinate in bulk and pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2020; 10(3): 129-33. DOI: 10.5958/2231-5675.2020. 00023.X
12. Matole V, Birajdar A, Ingle S, Adlinge S, Nangare G, Madur S, Patil S, Shegaonkar A. UV spectrophotometric method development and validation of acotiamide in bulk and solid doage form. Asian Journal of Pharmaceutical Analysis. 2020; 10(3): 147-9. DOI : 10.5958/2231-5675.2020.00026.5
13. Benazir SB, Archana J, Sumakanth M. Method development and validation of empagliflozin in bulk and pharmaceutical dosage form using UV spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 123-6. DOI: 10.52711/2231-5675.2021.00021
14. Kudatarkar N, Jalalpure S, Singadi R, Gurao R, Dinnimath B. Development And Validation Of UV-Visible Spectrophotometric Method For Estimation Of Chrysin In Bulk Form. Journal of Pharmaceutical Negative Results. 2022: 4758-63. DOI:10.47750/pnr.2022.13.S08.621
15. Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. International Journal of Applied Pharmaceutics. 2018; 10(6): 8-15. http://dx.doi.org/10.22159/ijap.2018v10i6.28279
16. Chethankumar H B et.al., Development and Validation of UV-Spectrophotometric Method for Estimation of Vinpocetine International Journal of Ayurvedic Medicine, 2023; Vol 14 (3), 717-723. DOI: https://doi.org/10.47552/ijam.v14i3.3585
17. Begum S, Jahnavi B, Jabeen N, Umema NT, Sandhya M. Method development and validation of evening primrose oil and its pharmaceutical dosage form by simple UV-spectrophotometric method. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 133-8. DOI : 10.52711/2231-5675.2021.00023
18. Taleuzzaman M. Limit of blank (LOB), limit of detection (LOD), and limit of quantification (LOQ). Org. Med. Chem. Int. J. 2018; 7(5). DOI: 10.19080/OMCIJ.2018.07.555722
19. Salunke PA, Barhate SD, Wagh RS. Environment safe Method development and Validation of Dolutegravir in Bulk and Tablet dosage form by UV-Visible spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 139-44. Salunke PA, Barhate SD, Wagh RS. Environment safe Method development and Validation of Dolutegravir in Bulk and Tablet dosage form by UV-Visible spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 139-44. DOI: 10.52711/2231-5675.2021.00024
20. Jha DK, Shah DS, Talele SR, Amin PD. Correlation of two validated methods for the quantification of naringenin in its solid dispersion: HPLC and UV spectrophotometric methods. SN Applied Sciences. 2020;2:1-1.https://doi.org/10.1007/s42452-020-2536-3
21. Mittha J, Habib B. UV spectrophotometric method development and validation of dasatinib in bulk and formulation. Asian Journal of Pharmaceutical Analysis. 2021; 11(3): 203-6. DOI: 10.52711/2231-5675.2021.00036
22. Kapatrala ST, Kondreddy VK, Kandlapalli S, Male T. Method development and validation for the estimation of etizolam and propranolol hydrochloride in bulk and combined dosage forms by simultaneous and derivative spectroscopic methods. Asian Journal of Pharmaceutical Analysis. 2021; 11(4): 263-9. DOI: 10.52711/2231-5675.2021.00045
23. Shetti P, Jalalpure SS. Optimization of a validated UV-spectrophotometric methodology for assessment of apigenin in bulk powder. IJPER. 2022; 56(1): 281-6. DOI: 10.5530/ijper.56.1.33
24. Ware AL, Pekamwar SS. Development and validation of bioanalytical uv-spectrophotometric method for determination of candesartan and development and validation of uv-spectrophotometric method for determination of candesartan in bulk drug and formulation. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 79-83. DOI: 10.52711/2231-5675.2021.00015
25. Sri RS, Sri KB, Sumakanth M. Stability indicating UV-Spectrophotometric method development and its validation for the determination of imatinib mesylate in bulk and formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(2): 83-6. DOI: 10.52711/2231-5675.2022.00015
26. Waghule T, Rapalli VK, Singhvi G, Manchanda P, Hans N, Dubey SK, Hasnain MS, Nayak AK. Voriconazole loaded nanostructured lipid carriers based topical delivery system: QbD based designing, characterization, in-vitro and ex-vivo evaluation. Journal of drug delivery science and technology. 2019; 52: 303-15. https://doi.org/10.1016/j.jddst.2019.04.026
27. Kempwade A, Taranalli A, Jadhav K. Development and validation of UV Spectrophotometric method to study stress degradation behaviour of Rizatriptan Benzoate. Spectroscopy and Spectral Analysis. 2015; 35(1): 137-40. https://doi.org/10.3964/j.issn.1000-0593(2015)01-0137-04
28. Kurangi B, Jalalpure S, Jagwani S. A validated stability-indicating HPLC method for simultaneous estimation of resveratrol and piperine in cubosome and human plasma. Journal of Chromatography B. 2019; 1122: 39-48. https://doi.org/10.1016/j.jchromb.2019.05.017
29. Jadhav KV, Dhamecha DL, Asnani GP, Patil PR, Patil MB. Stability-indicating stress degradation studies of lafutidine using UV spectrophotometric method. Pharmaceutical Methods. 2013; 4(1): 21-5. https://doi.org/10.1016/j.phme.2013.03.001
30. Agrawal YP, Agrawal MY, Jadhav SB, Shinde RJ. Development and validation of novel UV spectrophotometric method for the determination of evogliptin tartarate in pharmaceutical dosage form. Indian Journal of Pharmaceutical Education and Research. 2020; 54(4): 1174-9. DOI: 10.5530/ijper.54.4.214
31. Kurangi B, Jalalpure S. A validated stability-indicating RP-HPLC method for piperine estimation in black pepper, marketed formulation and nanoparticles. Indian J Pharm Educ Res. 2020; 54(3s): s677-86. DOI: 10.5530/ijper.54.3s.168
32. Chimagave SS, Jalalpure SS, Patil AK, Kurangi BK. Development and validation of stability indicating UV-spectrophotometric method for the estimation of hesperidin in bulk drugs, plant extract, Ayurveda formulation and nanoformulation. Indian J Pharm Educ Res. 2022; 56(3): 865-72. DOI: 10.5530/ijper.56.3.139