Abstract:In this work, the behavior of the active pharmaceutical substances methylprednisolone (in a form of methylprednisolone sodium succinate) in finished pharmaceutical dosage form, i.e., freeze-dried powder for injections, was examined. The goal was to evaluate the chemical stabilities of methylprednisolone sodium succinate packaged in a dual chamber vial, as a specific container closure system. The effect of different parameters: temperature, moisture and light were monitored. The method proposed by United States… Show more
“…Water for injection (WFI) was used in the analysis and passed through a 0.45 μm nylon membrane filter before use. Phosphate solution (1) was prepared by weighing 1.6 g of disodium hydrogen phosphate in 1000 mL of WFI. Phosphate solution (2) was prepared by weighing about 0.3 g of sodium dihydrogen phosphate in 1000 mL of WFI.…”
Section: Methodsmentioning
confidence: 99%
“…MPSS is the water-soluble corticosteroid ester of methylprednisolone and it is used for the treatment of cardiac, severe allergic reactions, hypoxic emergencies, respiratory diseases, ophthalmic diseases, dermatologic diseases, antineoplastic, hormonal, anti-inflammatory, neoplastic diseases, hematological disorders, nervous system conditions, and endocrine disorders. MPSS has the same anti-inflammatory and metabolism effects as methylprednisolone (MP) when administered parenterally and also at equal quantities, the two molecules have the same biologic action 1 . Figure 1 Structure of ( A ) methylprednisolone [MP], ( B ) methylprednisolone hemisuccinate [MPHS], ( C ) methylprednisolone 17-hemisuccinate [17-MPHS].…”
Section: Introductıonmentioning
confidence: 99%
“…There are many different methods with more than one technique in the analysis tools being conducted for the assay determination of MP, including flow injection analysis with LC-Q-TOF MS 5 , HPLC–MS 1 , RP-HPLC 6 – 9 , voltammetric techniques 10 , SWNTs/EPPGE 11 , spectrophotometrically 12 .…”
Section: Introductıonmentioning
confidence: 99%
“…Additionally, the separation process is a time consumed. Also, some methods used a high flow rate of 4.0 mL/min and a special column as Zorbax Eclipse XDB-C18 (250 mm × 9.4 mm; 5 μm) 1 . These factors are used to get the optimum peak shape with ideal tailing 18 , 19 .…”
Methylprednisolone sodium succinate (MPSS) is a parenteral water-soluble corticosteroid ester. It gives three peaks methylprednisolone (MP), 17-methylprednisolone hemisuccinate (17-MPHS), and methylprednisolone hemisuccinate (MPHS) that share in the assay determination as total MP. It is used on a wide scale in prescribed anti-inflammatory drugs as a common use. The current study aimed to find a rapid RP-HPLC method of MP and its derivatives analysis with high linearity, repeatability, sensitivity, selectivity, and inexpensive to use without the need for any special chemical reagents. The use of the current method achieved a satisfactory result to detect, determine and separate the MP, 17-MPHS, and MPHS in a short time. The chromatographic system consists of RP-HPLC using the BDS column (250 mm × 4.6 mm × 5 μm). The mobile phase was prepared by mixing the WFI: glacial acetic acid: acetonitrile in a volume ratio (63:2:35) at a flow rate of 2.0 mL/min with detection wavelength at 254 nm at room temperature and injection volume 20 μL. The method manifested a satisfied linearity regression R2 (0.9998–0.99999) with LOD 143.97 ng/mL and 4.49 µg/mL; and LOQ 436.27 ng/mL and 13.61 µg/mL for MP and MPHS respectively. The method proved its efficiency via system suitability achievement in the robustness and ruggedness conduction according to the validation guidelines. High sensitivity according to its LOD and LOQ. So, the current method could be considered in the pharmaceutical industry. The suggested method has been successfully implemented in the Egyptian local market for the quantitative assessment of the assay of the finished product.
“…Water for injection (WFI) was used in the analysis and passed through a 0.45 μm nylon membrane filter before use. Phosphate solution (1) was prepared by weighing 1.6 g of disodium hydrogen phosphate in 1000 mL of WFI. Phosphate solution (2) was prepared by weighing about 0.3 g of sodium dihydrogen phosphate in 1000 mL of WFI.…”
Section: Methodsmentioning
confidence: 99%
“…MPSS is the water-soluble corticosteroid ester of methylprednisolone and it is used for the treatment of cardiac, severe allergic reactions, hypoxic emergencies, respiratory diseases, ophthalmic diseases, dermatologic diseases, antineoplastic, hormonal, anti-inflammatory, neoplastic diseases, hematological disorders, nervous system conditions, and endocrine disorders. MPSS has the same anti-inflammatory and metabolism effects as methylprednisolone (MP) when administered parenterally and also at equal quantities, the two molecules have the same biologic action 1 . Figure 1 Structure of ( A ) methylprednisolone [MP], ( B ) methylprednisolone hemisuccinate [MPHS], ( C ) methylprednisolone 17-hemisuccinate [17-MPHS].…”
Section: Introductıonmentioning
confidence: 99%
“…There are many different methods with more than one technique in the analysis tools being conducted for the assay determination of MP, including flow injection analysis with LC-Q-TOF MS 5 , HPLC–MS 1 , RP-HPLC 6 – 9 , voltammetric techniques 10 , SWNTs/EPPGE 11 , spectrophotometrically 12 .…”
Section: Introductıonmentioning
confidence: 99%
“…Additionally, the separation process is a time consumed. Also, some methods used a high flow rate of 4.0 mL/min and a special column as Zorbax Eclipse XDB-C18 (250 mm × 9.4 mm; 5 μm) 1 . These factors are used to get the optimum peak shape with ideal tailing 18 , 19 .…”
Methylprednisolone sodium succinate (MPSS) is a parenteral water-soluble corticosteroid ester. It gives three peaks methylprednisolone (MP), 17-methylprednisolone hemisuccinate (17-MPHS), and methylprednisolone hemisuccinate (MPHS) that share in the assay determination as total MP. It is used on a wide scale in prescribed anti-inflammatory drugs as a common use. The current study aimed to find a rapid RP-HPLC method of MP and its derivatives analysis with high linearity, repeatability, sensitivity, selectivity, and inexpensive to use without the need for any special chemical reagents. The use of the current method achieved a satisfactory result to detect, determine and separate the MP, 17-MPHS, and MPHS in a short time. The chromatographic system consists of RP-HPLC using the BDS column (250 mm × 4.6 mm × 5 μm). The mobile phase was prepared by mixing the WFI: glacial acetic acid: acetonitrile in a volume ratio (63:2:35) at a flow rate of 2.0 mL/min with detection wavelength at 254 nm at room temperature and injection volume 20 μL. The method manifested a satisfied linearity regression R2 (0.9998–0.99999) with LOD 143.97 ng/mL and 4.49 µg/mL; and LOQ 436.27 ng/mL and 13.61 µg/mL for MP and MPHS respectively. The method proved its efficiency via system suitability achievement in the robustness and ruggedness conduction according to the validation guidelines. High sensitivity according to its LOD and LOQ. So, the current method could be considered in the pharmaceutical industry. The suggested method has been successfully implemented in the Egyptian local market for the quantitative assessment of the assay of the finished product.
“…in Singapore, the population over 65 years increase to about 316% in 2040). [7] Due to the quality of lifestyle in Iran, the knee arthritis has a very high prevalence and causes several problems for Iranians. Since the usual treatments in the form of long-lasting medications are costly and expensive for patients, and also, the lack of treatment causes morbidity and disability to earn a living on a daily basis, so it is necessary to adopt new and effective therapeutic measures as much as possible to provide the field for patients to back to work and to avoid additional costs.…”
Background and Objective: Pain is a common complaint in knee osteoarthritis (OA) and the main cause of functional disabilities among middle-aged and older persons. The conventional treatments are medications, administered in long-term and are costly with significant side effects. Therefore, it is necessary to develop new efficient therapeutic approaches part icularly those ones that allow the patients to continue their work. The present study aimed to comparatively investigate the pain relieving efficacy of intra-articular injection of methylprednisolone alone and combined ketamine-methylprednisolone in patients with knee OA. Materials and Methods: This is a double-blind clinical trial conducted on patients with knee OA. Seventy patients were randomly divided into two treatment groups (each group 35 cases aged 40-73 years old) of control and case groups. The control group received 40 mg methylprednisolone and 1 ml of distilled water and the case group received 40 mg of methylprednisolone along with ketamine (0.5 mg/kg) intra-articularly. The pain perceived by the patients was assessed using a visual analog scale (VAS) (at three-time points: Before injection, 1 month, and 3 months after injection). The amount of pain reduction was compared pre-and post-injection in each group and between the two groups. Results: The pain reduction in the control and case groups was the same at the 1 st month. The pain VAS score in the control group at the 3 month follow-up showed gradually increased. Conclusion: The VAS pain score showed a higher level of stability in the reduction of pain intensity in case group and these people experienced the reduction in the severity of pain for a longer time.
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