Stability indicating RP-HPLC method for estimation of cariprazine hydrochloride in human plasma
DOI:
https://doi.org/10.18231/j.joapr.2024.12.2.27.34Keywords:
Bioanalytical, Cariprazine Hydrochloride, Forced Degradation, Protein Precipitation extraction, RP-HPLC,, ValidationAbstract
Objective: The objective of the study is to create and validate the easy, dependable, accurate, sensitive, and selective RP-HPLC method for estimating Cariprazine HCl in human plasma. Methodology: The sample was prepared using the protein precipitation extraction method. The chromatographic separation was performed with an AGILENT C18 column (250mm x 4.6ID) as the stationary phase and a mobile phase consisting of a 75:25 v/v solution of Methanol and 0.1% Orthophosphoric acid at a flow rate of 0.7 ml/min. The DAD detector was used to carry out the detection at 253 nm. Cariprazine HCl had a reduced retention duration of 2.46 minutes. Results & Discussion: The calibration curve had a correlation coefficient of 0.998 and was linear over the concentration range of 1–5µg/ml. The method's accuracy was shown at levels between 80%, 100%, and 120% of the specification limit. The developed method exhibited excellent precision, with interday precision ranging from 0.07% to 1.77% and intraday precision from 0.03% to 0.26%. It was discovered that the recovery of Cariprazine HCl was within the 98% range. Cariprazine HCl was discovered to have a Limit of Detection (LOD) of 0.053µg/ml, and the Limit of Quantification was found to be 0.160µg/ml. Conclusion: The solution was injected in duplicate, and the % RSD was measured. The results indicate that the proposed method can be effectively utilized for the routine analysis of Cariprazine HCl in human plasma. The forced degradation studies indicate that the drug is susceptible to Hydrolytic and Photolytic degradation
Downloads
References
Tijare L, Rangari NT, Mahajan UN. A review on bioanalytical method development and Validation. Asian Journal of Pharmaceutical and Clinical Research, 9(3), 6 – 10 (2016).
Durgam S, Earley W, Li R, Li D, Lu K, Laszlovszky I, Fleischhacker WW, Nasrallah HA. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial. Schizophr Res, 176, 264-71 (2016).
Toujani E, Mejri W, Lassoued HE, Toujani S, Fliss O, Cheikh MHB, Safta F. Development and validation of a stability-indicating high-performance liquid chromatographic assay for determination of cariprazine in bulk form and drug product. Ann Pharm Fr, 81, 83-93 (2023).
Chiprikar P, Mastiholimath V. Method development and validation of cariprazine hydrochloride by UV spectrophotometric Method. Indian Journal of Novel Drug Delivery, 14(1), 52-57(2022).
Ghumarevaibhav M, Lahuhingane M. Development and validation of analytical method for estimation of cariprazine hydrochloride in bulk and tablet dosage form by using RP-HPLC Method. International Journal of Pharmaceutical Research and Applications, 7(3), 2280-94 (2022).
Sushma P, Pawar AK. Identification, separation, and mass spectral characterization of degradants in Cariprazine HCl by LC-MS/MS/QTOF. Journal of Chemical Metrology, 28(1),14–27 (2022).
Dandge VD, Malve V, Baitule AW. Development and validation of a bioanalytical method for determination of teneligliptin in human plasma by RP-HPLC. International Journal of PharmTech Research, 15(2), 48-57 (2022)
Krishna PS, Eswarudu MM, Priya NS, Gayathri B. Bioanalytical RP-HPLC Method Development and Validation for the determination of metformin hydrochloride in spiked human plasma. International Journal of Pharmaceutical Sciences Review and Research, Article No. 28, 165–168 (2022)
Gurumurthy T, Suresh PV. Bioanalytical Method Development and Validation of Eprosartan Mesylate and Hydrochlorthiazide using RP-HPLC in Human plasma. Research Journal of Pharmacy and Technology, 16(3), 1095-9 (2023)
Guidance for Industry, Bioanalytical Method Validation.; https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
Tamilselvi N, Sinha H, Visakh D, Vanathi P. Bio-analytical method development and validation for the estimation of Clotrimazole in human plasma by RP-HPLC method. Research Journal of Pharmacy and Technology, 9(6), 671-676 (2016).
D’cruz D, Babu A. Bioanalytical Method Development and Validation of Ticagrelor by RP-HPLC. International Journal of Applied Pharmaceutics, 9(3), 51–54 (2017).
Behera S, Mohapatra A, Sahu P, Mishra T. Teneligliptin: a literature review on analytical and bio-analytical methods. European Journal of Pharmaceutical and Medical Research, 8(11), 223–228 (2021).
Dandge VD, Malve V, Waghulkar VM, Baitule AW, Jawarkar SG. Development and Validation of a Bioanalytical Method for Determination of Teneligliptin in Human Plasma by RP-HPLC. International Journal of PharmTech Research, 15(2), 48-57 (2022).
Sabale V, Jiwankar M, Sabale P. Bioanalytical method development, validation and quantification of flutamide in spiked rat plasma by using high-performance liquid chromatography. Future J Pharm Sci., 9:75, 1–7 (2023).
Published
How to Cite
Issue
Section
Copyright (c) 2024 Mohini Shelke, Rahul Godge, Tejas Sahane, Onkar Pawar, Sujata Kasar
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
