SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION OF CHOLINE SALICYLATE AND TANNIC ACID USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

Authors

  • M. DAVID RAJU Department of Chemistry, PB Siddhartha College of Arts and Science, Vijayawada, A. P.

DOI:

https://doi.org/10.22159/ijap.2022v14i2.43625

Keywords:

HPLC, Choline salicylate, Tannic acid, Development, Validation

Abstract

Objective: The current investigation was pointed at completely unique and reliable high performance liquid chromatographic method for simultaneous quantification of Choline salicylate and Tannic acid.

Methods: Chromatographic separation was achieved on a symmetry C18 column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing 1 ml of OPA in l lt of HPLC marked water and acetonitrile within the percentage of 60:40 as movable phase with a flow rate of 1.0 ml/min at ambient temperature. Analysis was achieved within 15 min over an honest linearity within the concentration range from 4-60 µg/ml of choline salicylate and 2.5-37.5 µg/ml of tannic acid. Stress conditions of degradation in acidic, alkaline, peroxide and thermal was studied.

 Results: LOD and LOQ were observed as 1.21 µg/ml, 0.758 µg/ml and 4 µg/ml, 2.5 µg/ml of choline salicylate and tannic acid respectively. Precision and recovery study results were found to be within the suitable limit.

Conclusion: This developed method showed reliable, precise, accurate results under optimized conditions. The method was validated as reported by ICH guidelines. Hence it was evident that the proposed method was suitable for regular analysis and quality control of pharmaceutical preparations.

Downloads

Download data is not yet available.

References

Sven T, Reichenbach S, Wandel S, Hildebrand P, Tschannen B. Cardiovascular safety of non-steroidal anti-inflammatory drugs; network meta-analysis. Br Med J (Critical research Ed.). 2011;342:c7086.

Axelrod YK, Diringer MN. Temperature management in acute neurologic disorders. Neurol Clin. 2008;26(2):585-603, xi. doi: 10.1016/j.ncl.2008.02.005, PMID 18514828.

Section on Clinical Pharmacology and Therapeutics, Committee on Drugs, Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics. 2011;127(3):580-7. doi: 10.1542/peds.2010-3852, PMID 21357332.

Sarrell EM, Wielunsky E, Cohen HA. Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. Arch Pediatr Adolesc Med. 2006;160(2):197-202. doi: 10.1001/ archpedi.160.2.197, PMID 16461878.

Smolen JS, van der Heijde D, Machold KP, Aletaha D, Landewé R. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis. 2014;73(1):3-5. doi: 10.1136/annrheumdis-2013-204317, PMID 24072562.

Nandi P, Kingsley GH, Scott DL. Disease-modifying antirheumatic drugs other than methotrexate in rheumatoid arthritis and seronegative arthritis. Curr Opin Rheumatol. 2008;20(3):251-6. doi: 10.1097/BOR.0b013e3282fb7caa, PMID 18388514.

Shekelle PG, Newberry SJ, Fitzgerald JD, Motala A, O’Hanlon CE, Tariq A, Okunogbe A, Han D, Shanman R. Management of gout: a systematic review in support of an American college of physicians clinical practice guideline. Ann Intern Med. 2017;166(1):37-51. doi: 10.7326/M16-0461, PMID 27802478.

Van Durme CM, Wechalekar MD, Landewé RB. Nonsteroidal anti-inflammatory drugs for the treatment of acute gout. JAMA. 2015;313(22):2276-7. doi: 10.1001/jama.2015.1881, PMID 26057289.

Jones TD. The diagnosis of rheumatic fever. JAMA. 1944;126(8):481-4. doi: 10.1001/jama.1944.02850430015005.

Karthikeyan G, Guilherme L. Acute rheumatic fever. Lancet. 2018;392(10142):161-74. doi: 10.1016/S0140-6736(18)30999-1.

Singh JA, Cameron C, Noorbaloochi S, Cullis T, Tucker M, Christensen R, Ghogomu ET, Coyle D, Clifford T, Tugwell P, Wells GA. Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet. 2015;386(9990):258-65. doi: 10.1016/S0140-6736(14)61704-9, PMID 25975452.

Cutolo M, Kitas GD, van Riel PL. Burden of disease in treated rheumatoid arthritis patients: going beyond the joint. Semin Arthritis Rheum. 2014;43(4):479-88. doi: 10.1016/j.semarthrit.2013.08.004, PMID 24080116.

Fleming PS, Fedorowicz Z, Johal A, El-Angbawi A, Pandis N. Surgical adjunctive procedures for accelerating orthodontic treatment. Cochrane Database Syst Rev. 2015;(6):CD010572. doi: 10.1002/14651858.CD010572.pub2, PMID 26123284.

Millett DT, Cunningham SJ, O’Brien KD, Benson PE, de Oliveira CM. Orthodontic treatment for deep bite and retroclined upper front teeth in children. Cochrane Database Syst Rev. 2018;2:CD005972. doi: 10.1002/14651858.CD005972.pub4. PMID 29390172.

Shim YJ, Doo HK, Ahn SY, Kim YS, Seong JK, Park IS, Min BH. Inhibitory effect of aqueous extract from the gall of Rhus chinensis on alpha-glucosidase activity and postprandial blood glucose. J Ethnopharmacol. 2003;85(2-3):283-7. doi: 10.1016/s0378-8741(02)00370-7. PMID 12639753.

Supriya T, Naresh D, Vijaya Kumar G, Haneer MA. Stability indicating RP-HPLC method development and validation for simultaneous estimation of escitalopram and flupentixol pure and marketed formulation. Asian J Pharm Res. 2018;8:4-10.

Syed, Rafi, Kantipudi Rambabu. Stability indicating validated HPLC method for the determination of aceclofenac and misoprostol in bulk and pharmaceutical formulation. Int J Res Pharm Sci. 2020;11:7848-53.

Shanmugasundaram P, Kamarapu SK. RP-HPLC method for the simultaneous estimation and validation of amlodipine besylate and atenolol in bulk and tablet dosage form in biorelevant dissolution medium (Fassif). Res J Pharm Technol. 2017;10(10):3379-85. doi: 10.5958/0974-360X.2017.00601.1.

Manoranjani M. A study of method development, validation and forced degradation for simultaneous quantification of cisplatin and fluorouracil in bulk and pharmaceutical dosage form by RP-HPLC. J Pharm Sci Res. 2021;13:155-61.

Malathi S, Arunadevi N. Development and validation of stability-indicating simultaneous estimation of metformin and alogliptin in tablets by high-performance thin-layer chromatography. Int J Pharm Pharm Sci. 2020;12:68-73.

Yarlagadda SR, Mannam SR, Jampani BP. Stability indicating and cost-effective analytical method development and validation of sotorasib by using RP-HPLC. Int J App Pharm. 2021;13:154-9. doi: 10.22159/ijap.2021v13i5.42659.

Balaji Gupta VLN T, Venkateswara Rao B, Kishore Babu B. RP-HPLC (stability-indicating) based assay method for the simultaneous estimation of doravirine, tenofovir disoproxil fumarate and lamivudine. Int J Appl Pharm. 2021;13:153-9.

Gadhvi MP, Bhandari A, Suhagia BN, Desai UH. Development and validation of RP-HPLC method for simultaneous estimation of atazanavir and ritonavir in their combined tablet dosage form. Res J Pharm Technol. 2013;6:200-3.

Shivani CP, Maheshwari DG. Development and validation of UV spectrometric and HPLC method for estimation of escitalopram oxalate and flupentixol dihydrochloride in the combined dosage form. AJPTI. 2016;4:59-70.

Girija KS, Kasimala BB, Anna VR. A new high-performance liquid chromatography method for the separation and simultaneous quantification of eptifibatide and its impurities in pharmaceutical injection formulation. Int J App Pharm. 2021;13:165-72. doi: 10.22159/ijap.2021v13i2.39895.

Swati K, Abhishek P, Sushank S, Bothiraja C, Atmaram P. High-performance liquid chromatography for the simultaneous estimation of cefoperazone and sulbactam in rat plasma and its importance in therapeutic drug monitoring. Int J Pharm Pharm Sci. 2020;12:92-7.

Vijayakumari M, Reddy Ch B. Stability indicating validated hplc method for the determination of zanubrutinib in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res. 2020;13:159-62.

Rajakumari R, Sreenivasa Rao S. Stress degradation studies and development of a validated RP-HPLC method for determination of tiagabine in presence of its degradation products. Int J Pharm Pharm Sci. 2016;8:230-6.

International conference on the harmonization. ICH harmonized tripartite guideline. Validation of analytical procedures: text and methodology. Vol. Q2(R1); 2005.

Malak Y, Al-Bathish AA, Gazy MK. El-Jamal. Rp-hplc and chemometric methods for the determination of two anti-diabetic mixtures; metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide in their pharmaceutical formulation. Int J Pharm Pharm Sci. 2020;12:83-94.

Charu Pandya P, Sadhana Rajput J. Development and validation of stability indicating method RP-HPLC method of acotiamide. Int J Pharm Pharm Sci. 2018;10:1-8.

Athavia BA, Dedania ZR, Dedania RR, Swamy SMV, Prajapati CB. Stability indicating hplc method for determination of vilazodone hydrochloride. Int J Curr Pharm Sci 2017;9(4). doi: 10.22159/ijcpr.2017v9i4.20975.

Published

07-03-2022

How to Cite

RAJU, M. D. (2022). SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION OF CHOLINE SALICYLATE AND TANNIC ACID USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM. International Journal of Applied Pharmaceutics, 14(2), 227–232. https://doi.org/10.22159/ijap.2022v14i2.43625

Issue

Section

Original Article(s)