Development and Validation of New Analytical Method for The Simultaneous Estimation of Levodropropizine And Chlorpheniramine In Pharmaceutical Dosage Form
Abstract
A simple, Accurate, precise method was developed for the simultaneous estimation of the Levodropropizine and Chlorpheniramine in Tablet dosage form. The chromatogram was run through Ascentis C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer Kh2po4: Acetonitrile was taken in the ratio 40:60was pumped through the column at a flow rate of 1.0ml/min. The buffer used in this method was Kh2po4. The temperature was maintained at 30°C. The optimized wavelength selected was260nm. The retention time of Levodropropizine and Chlorpheniramine was found to be 2.276min and 2.848. %RSD of the Levodropropizine and Chlorpheniramine was and found to be 0.7 and 0.7 respectively. %Recovery was obtained as 100.73% and 99.03% for Levodropropizine and Chlorpheniramine respectively. LOD, LOQ values obtained from regression equations of Levodropropizine and Chlorpheniramine were 0.14, 0.02, and 0.43, 0.06 respectively. Regression equation of Levodropropizine is y = 67089x + 5956.8 and y = 226526x + 13941 of Chlorpheniramine. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.
Downloads
References
Nadiafa Y, Marianne N, Maissa S, Soheir A. Simultaneous determination of Levodropropizine, Methylparaben and Propyl paraben in oral co-formulated syrup by RP-HPLC method. Journal of the Chilean Chemical Society 2015; 60:2729-33.
Palakurthi A, Thummala V, Thirupathi D, Ravindra kumar, Jaya shree. Development and validation of a stabilityindicating LC-method for the simultaneous estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities. Scientia Pharmaceutica 2013; 81:139-50.
Rushikesh B, Atul N, Sanjay S. Analytical method development and validation of Phenylephrine hydrochloride, Chlorpheniramine maleate, Paracetamol and Caffeine in bulk drug and tablet dosage form by RP-HPLC. Indo American Journal of Pharmaceutical Research 2013; 3:4330-8.
Ramya V, Vijaya Lakshmi M, Pravallika M, Buchi N. Novel HPLC-PDA method for the estimation of Chlorpheniramine maleate in bulk and dosage forms. Indo American Journal of Pharmaceutical Research 2016; 6:6439-44.
Magesh AR, Dhanaraju MD. Development and validation of RP-HPLC method for simultaneous estimation of Diethylcarbamazine citrate and Chlorpheniramine maleate in pharmaceutical preparations. Chemical Science Transactions 2017; 6:316-22.
Madhusudan T, Shanbhag SV. Method development and validation by RP-HPLC for simultaneous estimation of Paracetamol, Caffeine, Phenylephrine, Chlorpheniramine in tablet dosage form. International Journal of Pharmacy and Technology 2017; 9:29960-70.
Vishal J, Mukesh C. Validated RP-HPLC method for determining the levels of Bromhexine hcl, Chlorpheniramine maleate, Dextromethorphan HBr and Guaiphenesin in their pharmaceutical dosage forms. Journal of Taibah University for Science. 2016; 10:38-45.
Sirigiri B, Chengalva P, Parameswari SA, Aruna G. A novel HPLC method for the simultaneous determination of Chlorpheniramine maleate and Dextromethorphan in bulk and pharmaceutical formulation. International Journal of Pharmaceutical Sciences and Research 2018; 9:1147-51.
Rao CP, Rahaman SA, Prasad YR, Reddy PG. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. International Journal of Pharmaceutical Research and Development. 2010 Nov;2(9):69-76.
International conference on harmonization tripartite guideline on validation of analytical procedures text and methodology: Q2 (R1); 2005.
Rao CM, Konda R, Ramanjeneeyulu S. Estimation of Nevirapine Anhydrous Bulk Formulation by Using IR, RP-HPLC, GC Methods. Research Journal of Pharmacy and Technology. 2010 Dec 28;3(4):1088-92.
Ch M M Prasada et al, Development and Validation of a Novel Stability Indicating RP-HPLC Method for The Estimation of Entecavir In Tablet Formulation, EJBPS, 2017, 4(7):176-180.
Kumaraswamy.Gandla, R.Lalitha, Dara Varun Kumar, and P.VR Teja Shruthi. “Analytical Method Development & Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and it’s Dosage Form by Rp-Hplc”. International Journal of Pharmaceutics and Drug Analysis, Apr. 2020, pp. 6-15,
Z. M. Sayyed, Aijaz A. Sheikh, Zakirhussain A. Shaikh, S. A. Shinde, . J. Chaware5, and K. R. Biyani. “DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF TENO-FOVIR AND EMTRICITABINE IN PHARMACEUTICAL DOSAGE FORMS BY HPLC”. International Journal of Pharmaceutics and Drug Analysis, Jan. 2016, pp. 24-29.
Gokul S. Sanap, Nilesh S. Zarekar, and Sarita S. Pawar. “REVIEW ON METHOD DEVELOPMENT AND VALIDATION”. International Journal of Pharmaceutics and Drug Analysis, May 2017, pp. 177-84,
Sirsat Bhagwat, Arsul Vilas A, and ArsulSupriya V. “Development And Validation Of Liquid Chromatography Method For The Analysis Of Atazanavir In Pharmaceutical Dosage Forms”. International Journal of Pharmaceutics and Drug Analysis, July 2018, pp. 563–570.
Kankipati Benjimen, K. Thejomoorthy, and P.Sreenivasa Prasanna. “Development and Validation of New Analytical Method for the Simultaneous Estimation of Daunorubicin and Cytarabine in Bulk and Pharmaceutical Dosage Form”. World Journal of Current Medical and Pharmaceutical Research, May 2021, pp. 32-39, doi:10.37022/wjcmpr.vi.171.

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

.