CONTENT VARIATIONS OF CARBAMAZEPINE TABLETS IN IRAQI COMMUNITY PHARMACIES: APPLICATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ASSAY METHOD

  • Mohanad Naji Sahib Department of Faculty of Pharmacy, Al-Rafidain University College, Baghdad, Iraq.

Abstract

 Objective: There is paucity in the literature and documentation regarding the post-marketing product quality in Iraq and Middle East countries in general. Therefore, a simple reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of carbamazepine (CMZ) content in post-marketed tablet dosage form.

Methods: The RP-HPLC analysis was run at a flow rate of 1 ml/min with a mixture of methanol: water (70:30) mobile phase using a Thermo Synchronise C18 column at a UV detection wavelength of 230 nm. The method was validated for selectivity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), solution stability, and robustness.

Results: The calibration curve was linear over a concentration range of 1–20 μg/ml (r2=0.9999) with LOD and LOQ of 0.01 and 0.04 μg/ml, respectively. The intraday and interday precision and accuracy were between 0.04–1.67% and 0.04–0.78%, respectively. The results of analysis of the four brands of CMZ tablets were passed the European Pharmacopoeia specification but with a high standard deviation of mean drug content of some brands.

Conclusion: This study shows that the quality of post-marketed drugs and/or the storage conditions in developing countries must be carefully assessed for a better therapeutic response.

Keywords: Carbamazepine, Drug content, High-performance liquid chromatography, Tablet quality.

References

1. Videau J, Fundafunda B. Generic Drugs: The Hidden issues of Quality and Cost. WHO Drug Inf 2000;14:77-81.
2. WHO. Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials. Report. Geneva: World Health Organization; 1997.
3. WHO. Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials. Report. Geneva: World Health Organization; 2007.
4. Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME. Counterfeit or substandard antimicrobial drugs: A review of the scientific evidence. J Antimicrob Chemother 2007;60:214-36.
5. WHO. Counterfeit Drugs. Guidelines for the Development of Measures to Combat Counterfeit Drugs. Report. Geneva: World Health Organization; 1999.
6. Moken MC. Fake pharmaceuticals: How they and relevant legislation or lack thereof contribute to consistently high and increasing drug prices. Am J Law Med 2003;29:525-42.
7. ICH. Validation of Analytical Procedures: Text and Methodology Q2 (R1). Report. Contract No.: 4/2. Geneva, Switzerland: ICH; 2005.
8. Neue U, Alden B, Iraneta P, Alberto M, Grumbach E, Tran K, et al. HPLC columns for pharmaceutical analysis. In: Ahuja S, Dong M, editors. Handbook of Pharmaceutical Analysis by HPLC. London: Elsevier Academic Press; 2005. p. 98-102.
9. Épshtein NA. Validation of HPLC techniques for pharmaceutical analysis. Pharm Chem J 2004;38:212-28.
10. European Pharmacopoeia. Uniformity of Content of Single-Dose Preparations; 2005.
11. Petralanda I. Quality of antimalarial drugs and resistance to plasmodium vivax in amazonian region. Lancet 1995;345:1433.
12. al-Zein H, Riad LE, Abd-Elbary A. Effect of packaging and storage on the stability of carbamazepine tablets. Drug Dev Ind Pharm 1999;25:223-7.
13. Yang D, Plianbangchang P, Visavarungroj N, Rujivipat S. Quality of pharmaceutical items available from drugstores in phnom penh, cambodia. Southeast Asian J Trop Med Public Health 2004;35:741-7.
14. Vinay R, Devi VK. Development and validation of a highly sensitive high-performance liquid chromatography (HPLC) method for the estimation of methotrexate (MTX) pure drug and marketed formulation in spiked rat plasma. Int J Pharm Pharm Sci 2016;8:313-7.
15. Rajoriya V, Soni A, Kashaw V. Method development and validation of fast dissolving tablet of ramipril by HPLC method. Int J Pharm Pharm Sci 2016;8:174-8.
Statistics
134 Views | 285 Downloads
How to Cite
Sahib, M. “CONTENT VARIATIONS OF CARBAMAZEPINE TABLETS IN IRAQI COMMUNITY PHARMACIES: APPLICATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ASSAY METHOD”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 11, no. 2, Feb. 2018, pp. 117-20, doi:10.22159/ajpcr.2018.v11i2.22739.
Section
Original Article(s)