The aim of this study was to investigate the stability of Carbocysteine (CBC) contained in a reference substance (RS) and in a sample of opened RHINATHIOL? 5% syrup (RNTL 5%) under the effect of some physicochemical parameters (temperature, light, time, pH, bile salts). The developed method was linear, precise and accurate according to USP 38. The co-efficient of determination R2 for linearity was 0.9993. The respective RSD of intra-day and inter-day between days (1st, 2nd and 3rd day) were respectively 0.338% and the interval from 0.05% to 0.387%. The average recovery rate ranged from 98.490% to 100.450%. The detection and quantification limits were 0.0001 mg/mL and 0.001 mg/mL respectively. The method was applied to four samples of opened syrup containing CBC and the CBC content in these samples was found to be in accordance with USP 38. The CBC content in the opened sample of RNTL 5% was obtained by UV-visible spectrophotometry at 217 nm and was 4.887 g/100mL. The study of the influence of physico-chemical factors on the content of CBC in RS and RNTL 5% showed that the evolution of CBC contents in each drug matrix remained dependent on pH and temperature. However, these levels remained stable in the presence of light.
References
[1]
Niaufre, C. (2014) Le trafic de faux médicaments en Afrique de l’Ouest: Filières d’approvisionnement et réseaux de distribution (Nigeria, Bénin, Togo, Ghana).
[2]
Rbah, Y. (2015) Les médicaments entamés: Etude dans les ménages de la ville de Salé.
[3]
Bouameur, S., Brahim, A., Bounab, M. and Khellifi, A. (2022) Stabilité des médicaments parentéraux dans le circuit hospitalier. Journal de La Faculté de Médecine.
[4]
(2003) Guideline I. Stability Testing of New Drug Substances and Products. Q1A (R2), Current Step; 4.
Kelesidis, T., Kelesidis, I., Rafailidis, P.I. and Falagas, M.E. (2007) Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence. Journal of Antimicrobial Chemotherapy, 60, 214-236. https://doi.org/10.1093/jac/dkm109
[7]
Vidjro, S.W. (2015) Etude de Stabilite D’UN Sirop de Paracetamol Pediatrique: Effet des Conditions de Conservation D’usage Courant.
[8]
Jassim, A.-M. (2010) In-Home Drug Storage and Self-Medication with Antimicrobial Drugs in Basrah, Iraq. Oman Medical Journal, 25, 79-87. https://doi.org/10.5001/omj.2010.25
[9]
Shankar, P., Kumar, P., Theodore, A., Partha, P. and Shenoy, N. (2003) A Survey of Drug Use Patterns in Western Nepal. Singapore Medical Journal, 44, 352-356.
[10]
Fainzang, S. (2003) Les médicaments dans l’espace privé: Gestion individuelle ou collective. Anthropologie et Sociétés, 27, 139-154. https://doi.org/10.7202/007450ar
[11]
(2009) The British Pharmacopoeia. Volume 1.
[12]
(n.d.) Vidal 2022, l’intélligence médicale au service du soin.
[13]
Davis, S. (2022) Carbocisteine. SA Pharmaceutical Journal, 89, 20-22.
[14]
Goebel, K. and Rolim, C.M.B. (2007) Validation of UV Spectrophotometric and HPLC Methods for Quantitative Determination of Atenolol in Pharmaceutical Preparations. Latin American Journal of Pharmacy, 26, 765-770.
[15]
Walash, M.I., El-Brashy, A.M., Metwally, M.E.-S. and Abdelal, A.A. (2004) Fluorimetric Determination of Carbocisteine and Ethionamide in Drug Formulation. Acta Chimica Slovenica, 51, 283-291.
[16]
Liang, Y.-Z., Xie, P. and Chan, K. (2004) Quality Control of Herbal Medicines. Journal of Chromatography B, 812, 53-70. https://doi.org/10.1016/S1570-0232(04)00676-2
[17]
Xie, P. (2005) Chromatography Fingerprint of Traditional Chinese Medicine. People’s Medical Publishing House, Beijing, 18-104.
[18]
Pargaonkar, G. and Kaskhedikar, S. (1994) Spectrophotometric Estimation of Amoxycillin and Carbocysteine in Single Dosage Forms by Complexation with Nickel (II). Indian Drugs Bombay, 31, 590-590.
[19]
Grant, K. and Quinn, M. (2018) Avantages du spectrophotomètre UV-Vis Cary 3500 multicuve pour l’analyse des protéines Améliorations de la productivité et de la reproductibilité pour les mesures qualitatives et quantitatives à très faibles volumes.
[20]
(2022) Guideline IHT. Validation of Analytical Procedures Q2 (R1).
[21]
(n.d.) USP 38-NF 33. The United States Pharmacopeia and National Formulary Version 2015 Main edition plus Supplements 1 and 2.
[22]
Rele, R. and Rane, D. (2017) Validation of Carbocisteine by Reversed Phase High Performance Liquid Chromatography Method from Active Pharmaceutical Dosage Form. International Journal of ChemTech Research, 10, 583-589.
[23]
Chauhan, K., Mujawar, A. and Quazi, I. (2016) HPTLC Method Development and Validation for Densitometric Analysis of Carbocisteine in Drug Formulation. International Journal of Applied Pharmaceutics, 8, 22-25.
[24]
Rele, R.V. (2014) Spectrophotometric Estimation of Carbocisteine in Bulk and Pharmaceutical Dosage Form by Second Order Derivative Method. Journal of Chemical and Pharmaceutical Research, 6, 118-122.
[25]
Taha, E.A., Hassan, N.Y., Abdel, A.F. and Abdel, F.L. (2008) Kinetic Spectrophotometic Determination of Acetylcysteine and Carbocisteine in Bulk Powder and in Drug Formulations. ScienceAsia, 34, 107-113. https://doi.org/10.2306/scienceasia1513-1874.2008.34.107