UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate
Abstract
:1. Introduction
2. Materials and Methods
2.1. Reagents and Equipment
2.2. Preparation of the 10% Solution of Sodium Carbonate
2.3. Preparation of the 50 mg/L Stock Solution of Nimesulide
2.4. Preparation of Working Solutions of Nimesulide
2.5. Preparation of Sample Solutions of Nimesulide from Tablets
2.6. Preparation of Swab Extracts of Nimesulide from Working Solution
2.7. Preparation of Swab Extracts of Nimesulide from Tablets
2.8. Preparation of the 50 mg/L Stock Solution of Meloxicam
2.9. Preparation of Working Solutions of Meloxicam
2.10. Preparation of Sample Solutions of Meloxicam from Tablets
2.11. Preparation of Swab Extracts of Meloxicam from Working Solution
2.12. Preparation of Swab Extracts of Meloxicam from Tablets
2.13. General Procedure for the Determination of Nimesulide
2.14. General Procedure for the Determination of Meloxicam
3. Results
3.1. Selection of the Wavelength
3.2. Selection of Sodium Carbonate Solution Concentration
3.3. Construction of the Calibration Graph
3.4. Analytical Performance
3.5. Linearity
3.6. Limit of Detection and Limit of Quantification
3.7. Selectivity with Respect to Common Excipients
3.8. Accuracy
3.9. Intra-Day Precision
3.10. Inter-Day Precision
3.11. Accuracy for the Determination of Model Swab Extract Solutions
3.12. Precision for the Determination of Model Swab Extract Solutions
3.13. Stability of Nimesulide and Meloxicam in the Sodium Carbonate Solutions
4. Discussion
5. Conclusions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Solvent | Used Reagents | Wavelength, nm | Linearity, mg/L | Accuracy, % | Precision, % | Reference |
---|---|---|---|---|---|---|
Methanol | None | 397 | Not specified | Not specified | Not specified | [8] |
Water | NaOH | 397 | 5–30 | 2 | 1 | [9] |
Water | Phosphate buffer | 393 | Not specified | Not specified | Not specified | [10] |
Methanol | Iminodibenzyl | 600 | 0.1–7.5 | 0.2 | 0.1 | [11] |
Methanol | 3-aminophenol | 470 | 0.4–12 | 0.3 | 0.2 | [11] |
Ethanol | None | 262–291 Second derivative | 2–90 | 2 | 1 | [12] |
Chloroform | None | 248–268 Second derivative | 2–50 | 3 | 1 | [12] |
Water/chloroform | Hexadecyl-trimethyl-ammonium bromide | 404 | 6–20 | 1 | 0.7 | [13] |
Water/chloroform | Bromocresol green | 412 | 2–18 | 5 | 0.6 | [14] |
Water/chloroform | Bromocresol purple | 410 | 2–16 | 4 | 0.5 | [14] |
Water/chloroform | Bromothymol blue | 407 | 2–18 | 3 | 0.5 | [14] |
Water/chloroform | Brilliant blue G | 502 | 2–18 | 5 | 0.5 | [14] |
Water/chloroform | Methyl orange | 482 | 2–14 | 3 | 0.7 | [14] |
Water | p-N,N-dimethyl phenylene diamine dihydrochloride, chloramine-T | 540 | 10–50 | 0.8 | 0.6 | [15] |
Water | p-N,N-dimethyl phenylene diamine dihydrochloride, 3-methyl-2-benzothiazolinone hydrazine hydrochloride | 600 | 12.5–75 | 1.2 | 0.4 | [15] |
Water | HNO2, cresyl fast violet acetate | 565 | 2–12 | 2.2 | 0.2 | [15] |
Water | p-methyl aminophenol sulphate, K2Cr2O7 | 550 | 20–120 | 0.8 | 0.5 | [15] |
Water | Thymol | 476 | 5–40 | 2.4 | 2.2 | [16] |
Water | NaOH | 397 | Not specified | Not specified | Not specified | [17] |
Water | NaOH | 397 | Not specified | Not specified | Not specified | [18] |
Water/acetonitrile | None | 300 | 10–50 | 1 | 0.4 | [19] |
Acetonitrile | None | 300 | 10–50 | 0.4 | 0.4 | [19] |
Methanol | Orcinol | 465 | 0.4–4 | 1.8 | 1.6 | [20] |
Water | NaOH | 460 | 0.4–5.1 | 8 | Not specified | [21] |
Methanol/water | Phloroglucinol, ammonium sulfamate | 400 | 4–20 | 2 | Not specified | [22] |
Methanol/water | p-dimethylamino benzaldehyde | 415 | 4–24 | 2 | Not specified | [22] |
Methanol | CuSO4, KNaC4H4O6, KI, NaOH | 400 | 25–200 | 0.8 | 2.1 | [23] |
Ethanol/water | Bromocresol green | 643 | 2–14 | 0.5 | 1.2 | [24] |
Ethanol/water | Bromocresol purple | 437 | 2–12 | 0.5 | 1.6 | [24] |
Ethanol/water | Brilliant blue G | 554 | 2–13 | 1 | 1.3 | [24] |
Methanol/water | N-bromosuccinimide, promethazine hydrochloride | 610 | 0.4–8 | Not specified | Not specified | [25] |
Methanol | None | 297 | 10–50 | 2 | Not specified | [26] |
Methanol/acetonitrile | None | 295 | 10–50 | 2 | Not specified | [26] |
Methanol | Folin–Ciocalteu reagent | 600 | Not specified | Not specified | Not specified | [27] |
Water | NaOH | 393 | 1.5–14 | Not specified | Not specified | [28] |
Methanol/water | 8-hydroxy-quinolinol | 480 | 0.5–25 | 1.6 | 1.2 | [29] |
Water | Sodium citrate, phenol | 390 | 10–40 | 3.6 | Not specified | [30] |
Water | Sodium benzoate, phenol | 390 | 10–50 | 1.5 | Not specified | [31] |
Water | KMnO4, Fast green FCF | 625 | Not specified | Not specified | Not specified | [32] |
Water | Na2CO3 | 397 | 5–25 | 6.4 | 3.4 | This work |
Solvent | Used Reagents | Wavelength, nm | Linearity, mg/L | Accuracy, % | Precision, % | Reference |
---|---|---|---|---|---|---|
Water | KMnO4, Fast green FCF | 625 | Not specified | Not specified | Not specified | [32] |
Methanol | FeCl3 | 570 | 2–200 | 2.3 | Not specified | [33] |
Water | NaOH | 362 | 0.5–20 | 1.9 | Not specified | [33] |
Water | Phosphate buffer | 362 | Not specified | Not specified | Not specified | [34] |
Methanol/acetonitrile | AlCl3 | 375 | 5–30 | 2.7 | 1.8 | [35] |
Ethanol | HCl, NaOH | 340–384 Difference spectrum | 2–10 | 0.5 | 0.8 | [36] |
Ethanol | HCl | 322–368 First derivative | 1–10 | 0.5 | 1.3 | [36] |
HCl | 343–385 Second derivative | 1–10 | 0.5 | 0.6 | [36] | |
Water/chloroform | Saframin T | 518 | 4–12 | 1 | 0.4 | [36] |
Water | N-bromosuccinimide, chloranilic acid | 530 | 10–160 | 8 | 1.2 | [37] |
Water/1,4-dioxan | UO2(NO3)2 | 398 | 5–60 | 1 | 1.5 | [38] |
Water/ethanol | AgNO3 | 412 | 1–15 | Not specified | 1.3 | [39] |
Methanol/water | 3-Methyl-2-benzothiazolinone-hydrazone hydrochloride, ceric ammonium sulphate | 450 | 2–20 | 1.0 | 0.5 | [40] |
Water | NaOH | 269 | 5–30 | 0.3 | 4.2 | [41] |
Water | FeCl3 | 476 | 50–250 | 0.5 | 2 | [41] |
Water | Trisodium citrate | 269 | 5–30 | 2.3 | 5.7 | [41] |
Water | Sodium nitroprusside, hydroxylamine | 363 | 4–20 | 3.8 | 1.5 | [42] |
Methanol/water | FeCl3, 1,10-phen-anthroline | 343 | 10–50 | 1.5 | 0.9 | [42] |
Water | FeCl3, K3[Fe(CN)6] | 770 | 0.25–2.5 | 1.2 | Not specified | [43] |
Water | Folin–Ciocalteu reagent | 740 | 5–15 | 0.4 | Not specified | [43] |
Water/1,4-dioxan/acetonitrile | HCl | 341 | 6–14 | 2.3 | 1.8 | [44] |
Water | Procaine benzylpenicillin | 492 | 5–80 | Not specified | Not specified | [45] |
Water | p-methyl aminophenol sulfate, NaIO4 | 656 | 15–225 | Not specified | Not specified | [45] |
Methanol/water/chloroform | Methylene blue | 654 | 1–5 | 1.2 | 2.3 | [46] |
Acetonitrile | 2,3-dichloro-5,6- dicyano-p-benzoquinone | 455 | 40–160 | 1 | 1 | [46] |
Methanol/water | Borate buffer | 363 | 0.5–30 | 1 | 1.4 | [47] |
Water | FeCl3, K3[Fe(CN)6] | 770 | 10–25 | 5 | Not specified | [48] |
Methanol/water | HCl | 346 | 5–150 | 3 | 0.5 | [49] |
Water | N-bromosuccinimide, indigo carmine | 610 | 0.2–50 | 1.5 | Not specified | [50] |
Methanol/water | NaOH | 365 | 2–12 | 1.1 | 1.3 | [51] |
Water | Phosphate buffer | 360 | 2–12 | 1.6 | 1.1 | [51] |
Methanol | UO2CO3 | 406 | 10–100 | 1 | Not specified | [52] |
Methanol | FeCl3 | 580 | 37.5–300 | 1 | Not specified | [52] |
Ethanol | FeCl3, K3[Fe(CN)6] | 708 | 0.1–11 | 1.3 | 0.7 | [53] |
Water | Orange G | 358 | 1–22 | 0.4 | 0.2 | [54] |
Water | Methylene blue | 652 | 1–22 | 0.2 | 0.2 | [54] |
Water | CuCl2 | 361 | 1–22 | 0.2 | 0.2 | [54] |
Water/chloroform | Bromocresol green | 415 | 10–50 | 0.8 | Not specified | [55] |
Water | NaOH | 361 | 4–14 | 1.2 | Not specified | [56] |
Water | NaOH | 270 | 4–14 | 4.2 | Not specified | [56] |
Water | NaOH | 215 | 4–14 | 5.5 | Not specified | [56] |
Water | NaOH | 386 First derivative | 4–14 | 1.3 | Not specified | [56] |
Water | NaOH | 340 First derivative | 4–14 | 1.5 | Not specified | [56] |
Water | NaOH | 273 First derivative | 4–14 | 3.4 | Not specified | [56] |
Water | NaOH | 257 First derivative | 4–14 | 4 | Not specified | [56] |
Water | NaOH | 409 Second derivative | 4–14 | 1.5 | Not specified | [56] |
Water | NaOH | 359 Second derivative | 4–14 | 1.4 | Not specified | [56] |
Water | NaOH | 316 Second derivative | 4–14 | 3.7 | Not specified | [56] |
Water | NaOH | 278 Second derivative | 4–14 | 2.4 | Not specified | [56] |
Water | NaOH | 269 Second derivative | 4–14 | 1.4 | Not specified | [56] |
Water | NaOH | 251 Second derivative | 4–14 | 2.2 | Not specified | [56] |
Water/acetone | 7-chloro-4-nitrobenz-2-oxa-1, 3-diazole | 460 | 0.5–4 | 1.7 | 1.3 | [57] |
Ethanol | None | 365 | 2–18 | 2.3 | 1.3 | [58] |
Water | NaNO2, HCl, sulfanilic acid | 365 | 1–20 | 3.5 | 2.3 | [59] |
Water | NaOH | 269 | 5–30 | 1.6 | 1.4 | [60] |
Water | NaOH | 253–279 Area under curve | 5–30 | 1.4 | 1.2 | [60] |
Water | NaOH | 275 First derivative | 50–300 | 1.5 | 1.6 | [60] |
Water | NaOH | 361 Fourth derivative | 5–35 | 0.6 | 3.4 | [61] |
Water | NaOH | 264–277, 352–378 Area under curve | 5–35 | 0.7 | 1.8 | [61] |
Water/methanol | 7-chloro-4-nitrobenz-2-oxa-1, 3-diazole | 461 | 0.5–5 | 5 | 4 | [62] |
Water | Folin–Ciocalteu reagent, Na2CO3 | 700 | 1.5–22.5 | 1.4 | Not specified | [63] |
Water | Na2CO3 | 362 | 5–25 | 5.4 | 3.7 | This work |
Parameter | Value | |
---|---|---|
Analyzed pharmaceutical ingredient | Nimesulide | Meloxicam |
Wavelength of maximum absorbance (nm) | 397 | 362 |
Slope and its confidence interval (f = 4, p = 95%) (L/mg) | 0.051 ± 0.001 | 0.038 ± 0.001 |
Intercept and its confidence interval (f = 4, p = 95%) | –0.002 ± 0.001 | –0.01 ± 0.01 |
R2 value | 0.999 | 0.996 |
Linearity range (mg/L) | 5–25 | 5–25 |
Ringbom’s optimum range (mg/L) | 4–14 | 6–18 |
Molar attenuation coefficient and its confidence interval (f = 4, p = 95%) (m2/mol) | 6100 ± 100 | 9100 ± 300 |
Sandell’s sensitivity coefficient and its confidence interval (f = 4, p = 95%) (μg/cm2) | 0.019 ± 0.002 | 0.026 ± 0.004 |
Limit of detection (mg/L) | 0.8 | 1.9 |
Limit of quantification (mg/L) | 2.5 | 5.8 |
Tested Solutions of Nimesulide | Mean Measured Concentration of Nimesulide (mg/L) | Relative Uncertainty (%) | Tested Solutions of Meloxicam | Mean Measured Concentration of Meloxicam (mg/L) | Relative Uncertainty (%) |
---|---|---|---|---|---|
Working solution, 5 mg/L | 5.06 | 1.2 | Working solution, 5 mg/L | 5.04 | 0.8 |
Working solution, 10 mg/L | 10.05 | 0.5 | Working solution, 10 mg/L | 10.04 | 0.4 |
Working solution, 15 mg/L | 15.06 | 0.4 | Working solution, 15 mg/L | 15.07 | 0.5 |
Working solution, 20 mg/L | 20.07 | 0.4 | Working solution, 20 mg/L | 20.05 | 0.3 |
Working solution, 25 mg/L | 25.09 | 0.4 | Working solution, 25 mg/L | 25.11 | 0.4 |
Sample solution from tablets, 5 mg/L | 4.96 | 0.8 | Sample solution from tablets, 5 mg/L | 4.94 | 1.2 |
Sample solution from tablets, 10 mg/L | 9.95 | 0.5 | Sample solution from tablets, 10 mg/L | 9.93 | 0.7 |
Sample solution from tablets, 15 mg/L | 14.93 | 0.5 | Sample solution from tablets, 15 mg/L | 14.95 | 0.3 |
Sample solution from tablets, 20 mg/L | 19.95 | 0.3 | Sample solution from tablets, 20 mg/L | 19.93 | 0.4 |
Sample solution from tablets, 25 mg/L | 24.92 | 0.3 | Sample solution from tablets, 25 mg/L | 24.91 | 0.4 |
Swab extract from working solution, 5 mg/L | 4.79 | 4.2 | Swab extract from working solution, 5 mg/L | 4.85 | 3.0 |
Swab extract from working solution, 10 mg/L | 9.81 | 1.9 | Swab extract from working solution, 10 mg/L | 9.87 | 1.3 |
Swab extract from working solution, 15 mg/L | 14.76 | 1.6 | Swab extract from working solution, 15 mg/L | 14.84 | 1.1 |
Swab extract from working solution, 20 mg/L | 19.69 | 1.2 | Swab extract from working solution, 20 mg/L | 19.73 | 1.2 |
Swab extract from working solution, 25 mg/L | 24.72 | 1.1 | Swab extract from working solution, 25 mg/L | 24.77 | 1.0 |
Swab extract from sample solution from tablets, 5 mg/L | 4.68 | 6.4 | Swab extract from sample solution from tablets, 5 mg/L | 4.73 | 5.4 |
Swab extract from sample solution from tablets, 10 mg/L | 9.70 | 3.0 | Swab extract from sample solution from tablets, 10 mg/L | 9.76 | 2.4 |
Swab extract from sample solution from tablets, 15 mg/L | 14.66 | 2.3 | Swab extract from sample solution from tablets, 15 mg/L | 14.69 | 2.0 |
Swab extract from sample solution from tablets, 20 mg/L | 19.62 | 1.9 | Swab extract from sample solution from tablets, 20 mg/L | 19.65 | 1.7 |
Swab extract from sample solution from tablets, 25 mg/L | 24.57 | 1.7 | Swab extract from sample solution from tablets, 25 mg/L | 24.66 | 1.4 |
Tested Solutions of Nimesulide | Standard Deviation (mg/L) | Relative Standard Deviation (%) | Tested Solutions of Meloxicam | Standard Deviation (mg/L) | Relative Standard Deviation (%) |
---|---|---|---|---|---|
Working solution, 5 mg/L (intra-day) | 0.07 | 1.4 | Working solution, 5 mg/L (intra-day) | 0.08 | 1.6 |
Working solution, 10 mg/L (intra-day) | 0.11 | 1.1 | Working solution, 10 mg/L (intra-day) | 0.13 | 1.3 |
Working solution, 15 mg/L (intra-day) | 0.14 | 0.9 | Working solution, 15 mg/L (intra-day) | 0.15 | 1.0 |
Working solution, 20 mg/L (intra-day) | 0.14 | 0.7 | Working solution, 20 mg/L (intra-day) | 0.18 | 0.9 |
Working solution, 25 mg/L (intra-day) | 0.15 | 0.6 | Working solution, 25 mg/L (intra-day) | 0.20 | 0.8 |
Sample solution from tablets, 5 mg/L (intra-day) | 0.06 | 1.3 | Sample solution from tablets, 5 mg/L (intra-day) | 0.08 | 1.6 |
Sample solution from tablets, 10 mg/L (intra-day) | 0.10 | 1.0 | Sample solution from tablets, 10 mg/L (intra-day) | 0.12 | 1.2 |
Sample solution from tablets, 15 mg/L (intra-day) | 0.12 | 0.8 | Sample solution from tablets, 15 mg/L (intra-day) | 0.13 | 0.9 |
Sample solution from tablets, 20 mg/L (intra-day) | 0.12 | 0.6 | Sample solution from tablets, 20 mg/L (intra-day) | 0.16 | 0.8 |
Sample solution from tablets, 25 mg/L (intra-day) | 0.17 | 0.7 | Sample solution from tablets, 25 mg/L (intra-day) | 0.17 | 0.7 |
Working solution, 5 mg/L (inter-day) | 0.09 | 1.8 | Working solution, 5 mg/L (inter-day) | 0.11 | 2.1 |
Working solution, 10 mg/L (inter-day) | 0.12 | 1.2 | Working solution, 10 mg/L (inter-day) | 0.15 | 1.5 |
Working solution, 15 mg/L (inter-day) | 0.15 | 1.0 | Working solution, 15 mg/L (inter-day) | 0.18 | 1.2 |
Working solution, 20 mg/L (inter-day) | 0.16 | 0.8 | Working solution, 20 mg/L (inter-day) | 0.20 | 1.0 |
Working solution, 25 mg/L (inter-day) | 0.18 | 0.7 | Working solution, 25 mg/L (inter-day) | 0.23 | 0.9 |
Sample solution from tablets, 5 mg/L (inter-day) | 0.08 | 1.7 | Sample solution from tablets, 5 mg/L (inter-day) | 0.09 | 1.9 |
Sample solution from tablets, 10 mg/L (inter-day) | 0.15 | 1.5 | Sample solution from tablets, 10 mg/L (inter-day) | 0.17 | 1.7 |
Sample solution from tablets, 15 mg/L (inter-day) | 0.16 | 1.1 | Sample solution from tablets, 15 mg/L (inter-day) | 0.19 | 1.3 |
Sample solution from tablets, 20 mg/L (inter-day) | 0.18 | 0.9 | Sample solution from tablets, 20 mg/L (inter-day) | 0.22 | 1.1 |
Sample solution from tablets, 25 mg/L (inter-day) | 0.20 | 0.8 | Sample solution from tablets, 25 mg/L (inter-day) | 0.25 | 1.0 |
Swab extract from working solution, 5 mg/L | 0.15 | 3.2 | Swab extract from working solution, 5 mg/L | 0.17 | 3.6 |
Swab extract from working solution, 10 mg/L | 0.23 | 2.3 | Swab extract from working solution, 10 mg/L | 0.27 | 2.7 |
Swab extract from working solution, 15 mg/L | 0.24 | 1.6 | Swab extract from working solution, 15 mg/L | 0.27 | 1.8 |
Swab extract from working solution, 20 mg/L | 0.26 | 1.3 | Swab extract from working solution, 20 mg/L | 0.32 | 1.6 |
Swab extract from working solution, 25 mg/L | 0.30 | 1.2 | Swab extract from working solution, 25 mg/L | 0.32 | 1.3 |
Swab extract from sample solution from tablets, 5 mg/L | 0.16 | 3.4 | Swab extract from sample solution from tablets, 5 mg/L | 0.18 | 3.7 |
Swab extract from sample solution from tablets, 10 mg/L | 0.26 | 2.7 | Swab extract from sample solution from tablets, 10 mg/L | 0.29 | 3.0 |
Swab extract from sample solution from tablets, 15 mg/L | 0.28 | 1.9 | Swab extract from sample solution from tablets, 15 mg/L | 0.35 | 2.4 |
Swab extract from sample solution from tablets, 20 mg/L | 0.31 | 1.6 | Swab extract from sample solution from tablets, 20 mg/L | 0.37 | 1.9 |
Swab extract from sample solution from tablets, 25 mg/L | 0.34 | 1.4 | Swab extract from sample solution from tablets, 25 mg/L | 0.42 | 1.7 |
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Nikolaychuk, P.A. UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate. J 2023, 6, 248-266. https://doi.org/10.3390/j6020019
Nikolaychuk PA. UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate. J. 2023; 6(2):248-266. https://doi.org/10.3390/j6020019
Chicago/Turabian StyleNikolaychuk, Pavel Anatolyevich. 2023. "UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate" J 6, no. 2: 248-266. https://doi.org/10.3390/j6020019