Simultaneous determination of metronidazole and spiramycin in bulk powder and in tablets using different
Fatma I Khattab1, Nesrin K Ramadan, Maha A Hegazy
1Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr el Aini Street, 11562, Cairo, Egypt.
Abstract:
Metronidazole (MZ) is an anti-infective drug used in the treatment of anaerobic bacterial and protozoa infections in humans. It is also used as a veterinary antiparasitic drug. Spiramycin (SP) is a medium-spectrum antibiotic with high effectiveness against Gram-positive bacteria. Three simple, sensitive, selective and precise spectrophotometric methods were developed and validated for the simultaneous determination of MZ and SP in their pure form and in pharmaceutical formulations. In methods A and B, MZ was determined by the application of direct spectrophotometry and by measuring its zero-order (D(0)) absorption spectra at its λ(max) = 311 nm. In method A, SP was determined by the application of first derivative spectrophotometry (D(1)) and by measuring the amplitude at 218.3 nm. In method B, the first derivative of the ratio spectra (DD(1)) was applied, and SP was determined by measuring the peak amplitude at 245.6 nm. Method C entailed mean centering of the ratio spectra (MCR), which allows the determination of both MZ and SP. The methods developed were used for the determination of MZ and SP over a concentration range of 5-25 µg ml(-1). The proposed methods were used to determine both drugs in their pure, powdered forms with mean percentage recoveries of 100.16 ± 0.73 for MZ in methods A and B, 101.10 ± 0.90 in method C, 100.09 ± 0.70, 100.02 ± 0.88 and 100.49 ± 1.26 for SP in methods A, B and C, respectively. The proposed methods were proved using laboratory-prepared mixtures of the two drugs and were successfully applied to the analysis of MZ and SP in tablet formulation without any interference from each other or from the excipients. The results obtained by applying the proposed methods were compared statistically with a reported HPLC method and no significant difference was observed between these methods regarding both accuracy and precision.
Insights
Three spectrophotometric methods accurately determine Metronidazole (MZ) and Spiramycin (SP) simultaneously in pharmaceutical formulations. These validated methods offer precise quantification of these essential anti-infective and antibiotic drugs.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Spectrophotometry
Background:
- Metronidazole (MZ) is a key anti-infective agent for anaerobic bacterial and protozoa infections.
- Spiramycin (SP) is an effective antibiotic against Gram-positive bacteria.
- Simultaneous determination of these drugs in formulations is crucial for quality control.
Purpose of the Study:
- To develop and validate simple, sensitive, and selective spectrophotometric methods.
- To enable simultaneous determination of Metronidazole (MZ) and Spiramycin (SP).
- To quantify these drugs in both pure forms and pharmaceutical formulations.
Main Methods:
- Method A & B: Direct spectrophotometry (zero-order) for MZ; First derivative spectrophotometry (D(1)) for SP (Method A).
- Method B: First derivative of ratio spectra (DD(1)) for SP determination.
- Method C: Mean centering of ratio spectra (MCR) for simultaneous determination of both MZ and SP.
Main Results:
- All developed methods successfully quantified MZ and SP within the 5-25 µg ml⁻¹ concentration range.
- High mean percentage recoveries (approx. 100%) were achieved for both drugs in pure and powdered forms.
- Methods were validated for tablet formulations, showing no interference from excipients and comparable results to HPLC.
Conclusions:
- The proposed spectrophotometric methods are accurate, precise, and suitable for simultaneous analysis of MZ and SP.
- These methods offer a reliable alternative for quality control of pharmaceutical products containing both drugs.
- The validated techniques ensure accurate drug content determination without interference.
