Development and Validation of a SimpleHigh-pressure Liquid Chromatography-Ultraviolet Detection Method for Simultaneous Quantitation of First-LineAnti-Tuberculosis Drugs in Formulations of Fixed-Dose Combination

Vilvamani, Sudha and Mahalingam, Santhana Mahalingam and Nhavilthodi, Sruthi and Murugesan, Dharman and Shanmugam Murugaiha, Jeyakumar (2024) Development and Validation of a SimpleHigh-pressure Liquid Chromatography-Ultraviolet Detection Method for Simultaneous Quantitation of First-LineAnti-Tuberculosis Drugs in Formulations of Fixed-Dose Combination. Chromatography-Ultraviolet Detection Method for Simultaneous Quantitation of First-LineAnti-Tuberculosis Drugs in Formulations of Fixed-Dose Combination, 62 (9). pp. 821-828.

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Abstract

The current treatment protocol for drug-sensitive tuberculosis involves all four first-line anti-tuberculosis drugs: rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride in a single tablet, known as fixed-dose combination tablets. However, the analytical methods are scanty to test all these drugs simultaneously in a single run without any pre-sample process or using a simple method suitable for resource-limited settings. In this method, 50 mM potassium phosphate buffer containing 0.2% triethylamine (without pH adjustment) added with acetonitrile (98:2, v/v) was served as mobile phase A, while mobile phase B was 100% acetonitrile. All four drugs were separated within 10.3 min using a gradient mobile phase program in a C18 column (150 mm × 4.6 mm; 5 μm) and detected at two ultraviolet wavelengths (238 nm for rifampicin, isoniazid and pyrazinamide, and 210 nm for ethambutol hydrochloride). The method was selective, sensitive and linear with a correlation coefficient >0.999 with the acceptable precision and accuracy (<2% relative standard deviation) for all four drugs. In conclusion, the method is simple and it does not require any pH adjustment of the buffer/mobile phase, and within 11 min, the separation of all four drugs can be achieved. Overall, the method is suitable for quality testing of fixed-dose combination tablets in limited-resource settings.

Affiliation:	ICMR-National Institute for Research in Tuberculosis
Item Type:	Article
Uncontrolled Keywords:	DevelopmentandValidation, drug-sensitivetuberculosis, first-lineanti-tuberculosisdrugs, pulmonaryTB, Pharmaceuticalformulations
Subjects:	Tuberculosis > Laboratory Research Tuberculosis Tuberculosis > Laboratory Research > Pharmacological
Divisions:	Basic Science Research > Clinical Pharmacology
Depositing User:	Mrs. N Lakshmi
Date Deposited:	16 Apr 2025 10:49
Last Modified:	16 Apr 2025 10:49
URI:	http://eprints.nirt.res.in/id/eprint/2035

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