DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD OF PALIPERIDONE PALMITATE IN BULK AND ITS APPLICATION FOR DRUG LOADING AND ENTRAPMENT EFFICIENCY ANALYSIS OF LONG-ACTING INJECTABLE MICROSPHERES

Authors

  • SANDIP MALI Department of Pharmaceutical Science, Research, Development and Innovation Centre (RDIC), C. U. Shah University, Wadhwan City, Surendranagar 363030, Gujarat, India
  • NISHANT OZA Department of Pharmaceutical Science, Research, Development and Innovation Centre (RDIC), C. U. Shah University, Wadhwan City, Surendranagar 363030, Gujarat, India

DOI:

https://doi.org/10.22159/ijap.2021v13i4.41583

Keywords:

UV spectroscopy, Method validation, Paliperidone palmitate, Stress degradation, Drug loading, Microspheres

Abstract

Objective: The objective of the current study was to develop simple, precise and cost-effective ultraviolet (UV) spectroscopic method for estimation of paliperidone palmitate (PP) as a bulk and in the polymeric depot dosage form.

Methods: UV spectrophotometer with quartz sample cells and spectral manager software was used for analysis samples. 20 % Methanol in Mili-Q-Water was used as a solvent for the sample and standard preparations. Method validation was carried out as per ICH Q2 (R1) guidelines. Stress degradation studies were carried out to check the stability-indicating performance of the developed method. The validated method was applied for the estimation of the PP content of long-acting injectable microspheres of PP.

Results: The wavelength of maximum absorption was found to be 283 nm. The proposed method was validated in the range of 5-30 µg/ml of PP. The mean recovery for 80%, 100% and 120% standard solution was found to be 99.03%, 99.21% and 99.35% respectively with less than 2% relative standard deviation (RSD). Intra-day and inter-day method precision ranged from 0.54 to 1.62% and 0.67 and 1.24% respectively. Limit of detection (LOD) and limit of quantitation (LOQ) were estimated to be 0.03 and 0.10 µg/ml respectively. The developed method was found to be robust and rugged. Stress degradation studies were carried out under acidic, alkaline, hydrolytic and oxidative and photo stress. The proposed method was capable to detect changes in assay due to stress conditions.

Conclusion: The developed method was successfully employed for routine analysis of drug loading in long-acting injectable microspheres of PP.

Downloads

Download data is not yet available.

References

Dixon LB, Lehman AF, Levine J. Conventional antipsychotic medications for schizophrenia. Schizophr 1995;21:567.

Chue P, Chue J. A critical appraisal of paliperidone long-acting injection in the treatment of the schizoaffective disorder. Ther Clin Risk Manag 2016;27:109–16.

Samtani MN, Vermeulen A, Stuyckens K. Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet 2009;48:585–600.

Bishara D. Once monthly paliperidone injection for the treatment of schizophrenia. Neuropsych Dis Treatment 2010;6:561–72.

Fang Y, Zhang N, Li Q, Chen J, Xiong S, Pan W. Characterizing the release mechanism of donepezil loaded PLGA microspheres in vitro and in vivo. J Drug Delivery Sci Technol 2019;51:430-7.

Andharia JV, Shen J, Choi S, Wang Y, Zou Y, Burgess DJ. Development of in vitro-in vivo correlation of parenteral naltrexone loaded polymeric microspheres. J Controlled Release 2017;255:27-35.

Zhang C, Wu l, Tao A, Bera H, Tang X, Cun D, et al. Formulation and in vitro characterization of long-acting PLGA injectable microspheres encapsulating a peptide analog of LHRH. J Mater Sci Technol 2021;63:133-44.

Thakur B, Kumar I. New developed and validated spectroscopic method for the simultaneous estimation of terbinafine hydrochloride and fluconazole. Int J Pharm Pharm Sci 2020;12:19-25.

Pokala RV, Kumari K, Bollokola HB. UV spectroscopy method development and validation of Sulfadiazine and Trimethoprim in combined dosage form. Int J Pharm Pharm Sci 2018;10:103-7.

Atole DM, Rajput HH. Ultraviolet spectroscopy and its pharmaceutical applications-a brief review. Asian J Pharm Clin Res 2018;11:59-66.

Yadav N, Goyal A. A validated spectrophotometric method for determination of Vilazodone hydrochloride in pharmaceutical dosage form. Int J Curr Pharm Res 2017;9:132-5.

Satya T, Yadav GKS, Chakarvarth IE. New simple UV-spectrophotometric determination of paliperidone palmitate in tablets. Int J Eng Sci Res Tech 2014;3:411-3.

Patil SV, Shirkhedkar AA. Application of uv-spectrophotometry and rp-hptlc methods for estimation of paliperidone in bulk and tablets. J Globe Trends Pharm Sci 2015;6:2770–6.

Trivedi RK, Jupudi R, Patel MC, Trivedi DR, Jogia HA. A validated Spectrophotometric method for determination of paliperidone palmitate in bulk drug and its pharmaceutical dosage form. J Pharm Pharm Sci 2013;2:37-41.

Jane M, Joshi C, Jonils A. Analytical methods for estimation of paliperidone. Int J Res Pharm 2011;2:158-61.

Rudragangaiah S, Bhatta RG, Kottapa SB. Stability indicating RP-HPLC method for the quantification of paliperidone in bulk and solid dosage form to establish validation and stability-indicating parameters. Indian J Pharma Educ Res 2019;53(4s):691-8.

Sherje AP, Londhe V. Stability indicating HPLC method for determination of paliperidone in bulk. Int J Pharmatech Res 2015;8:157-63.

Trivedi RK, Jain P, Patel MC, Chatrabhuji PM, Trived DR. A rapid, stability-indicating RP-UPLC method for determination of paliperidone palmitate in a depot injectable formulation. J Appl Pharm Sci 2013;3:87-92.

ICH. Validation of Analytical Procedure, Text and Methodology Q2(R1), International Conference on Harmonization, IFPMA, Geneva, Switzerland; 2005.

Martins YA, Oliveira CL. Development and validation of an UV spectroscopic method for determination of thiamphenicol in dosage form. J Appl Spectrosc 2019;86:629-35.

Prasad AR, Thireesha B. UV spectrophotometric method development and validation for determination of lornoxicam in microsponges. Int J Appl Pharm 2018;10:74-8.

Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-a review. J Pharma Anal 2014;4:159-65.

Doredla NR, Yengisetty B. Method development and validation of forced degradation studies of pioglitazone hydrochloride by using UV spectroscopy. Int J Pharmatech Res 2012;4:1750-7.

Devi V, Sekar V. Stress degradation studies of hydrochlorothiazide and development of a validated method by UV spectroscopy. Int J Sci Res 2018;7:403-6.

ICH. Photostability testing of new active substances and products Q1B(R4), International Conference on Harmonization, IFPMA, Geneva, Switzerland; 1996.

Dey S, Pramanik S, Malgope A. Formulation and optimization of sustained-release stavudine microspheres using response surface methodology. Int Sch Res Notices; 2011. p. 627-33.

Chen W, Palazzo A, Henrick WE, Kok RJ. Effect of particle size on drug loading and release kinetics of gefitinib-loaded PLGA microspheres. Mol Pharm 2017;14:459-67.

Reddy KA, Karpagam S. Preparation and characterization of drug-loaded phthalic anhydride based hyperbranched polyesteramides microspheres. Pharm Chem J 2017;50:857-64.

Sawant SD, Barge VU. Identification and characterization of forced degradation products of paliperidone palmitate using LC-APCI-Ion trap-MS. J Pharm Res 2013;6:39-47.

Mathad VT, Jadhav SA, Landge SB, Choudhari PM, Solanki PV, Bembalkar SR. Stress degradation behavior of paliperidone, an antipsychotic drug and development of suitable stability-indicating RP-LC method. Chromatogr Res Int 2011:1-10. https://doi.org/10.4061/2011/256812

ICH. Stability testing of new drug substances and products Q1A(R2), International Conference on Harmonization, IFPMA, Geneva, Switzerland; 2003.

Published

07-07-2021

How to Cite

MALI, S., & OZA, N. (2021). DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD OF PALIPERIDONE PALMITATE IN BULK AND ITS APPLICATION FOR DRUG LOADING AND ENTRAPMENT EFFICIENCY ANALYSIS OF LONG-ACTING INJECTABLE MICROSPHERES. International Journal of Applied Pharmaceutics, 13(4), 87–93. https://doi.org/10.22159/ijap.2021v13i4.41583

Issue

Section

Original Article(s)