Strategy of pulseless pink supracondylar humerus fracture treatment in children: a comparison of two approaches.

PURPOSE: The appropriate treatment of pulseless pink supracondylar humerus fractures (SCHF) remains controversial. In this study, the outcomes of two treatment approaches (with and without vascular surgery) were compared. MATERIAL AND METHODS: This was a retrospective multicenter study of patients with pulseless pink SCHFs treated in ten pediatric surgery, trauma, or orthopedics departments in the Czech and Slovak Republic between 2014 and 2018. RESULTS: Of the total 3608 cases of displaced SCHF, 125 had the pulseless pink SCHF. Of those, 91% (114/125) did not undergo vascular surgery and 9% (11/125) underwent vascular surgery. The patients who did undergo vascular surgery had radial artery pulsation restored more frequently in the operating room (73% vs. 36%; p = 0.02), within 6 h (91% vs. 45%; p = 0.004), and within 24 h of surgery (91% vs. 57%; p = 0.05). However, 72 h after surgery, there was no significant difference in palpable radial artery pulsation between the vascular surgery and the non-vascular surgery groups (91% vs. 74%; p = 0.24). Additionally, no significant differences in long-term neurological (9% vs. 22%; p = 0.46) or circulatory (9% vs. 7%; p = 0.57) deficits were found between the two groups. CONCLUSION: While vascular surgery in patients with pulseless pink SCHFs is associated with a more prompt restoration of radial artery pulsation, no statistical significant differences in terms of the restoration of neurological deficits or the risks of long-term neurological or circulatory deficits were found between patients with and without vascular surgery.

A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form.

A new rapid stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form was developed. The separation of Ph. Eur. related substances of amlodipine besylate (A, B, D, E, F, G), hydrochlorothiazide (A, B, C), valsartan (B, C), two other valsartan impurities (S)-2-(N-{[2'-cyanobiphenyl-4-yl]methyl}pentanamido)-3-methylbutanoic acid and (S)-3-methyl-2-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methylamino}butanoic acid and several unknown impurities was achieved by reversed phase liquid chromatography with UV detection. The detection wavelengths were set as follows: 225nm for valsartan, its impurities and for the impurity D of amlodipine, 271nm for hydrochlorothiazide and its impurities and 360nm for amlodipine and its impurities except for impurity D. Zorbax Eclipse C8 RRHD (100mm×3.0mm, 1.8µm) was used as a separation column and the analytes were eluted within 11min by a programmed gradient mixture of 0.01M phosphate buffer pH 2.5 and acetonitrile. The method was successfully validated in accordance to the International Conference of Harmonization (ICH) guidelines for amlodipine besylate and its impurity D, valsartan and its impurity C and hydrochlorothiazide and its impurities A, B and C. The triple-combined tablets were exposed to thermal, higher humidity, acid, alkaline, oxidative and photolytic stress conditions. Stressed samples were analyzed by the proposed method. All the significant degradation products and impurities were satisfactory separated from each other and from the principal peaks of drug substances. The peak purity test complied for peaks of amlodipine, valsartan and hydrochlorothiazide in all the stressed samples and indicated no co-elution of degradation products. The method was found to be precise, linear, accurate, sensitive, specific, robust and stability-indicating and could be used as a routine purity test method for amlodipine besylate, valsartan, hydrochlorothiazide and their pharmaceutical combinations.

Separation and determination of impurities in paracetamol, codeine and pitophenone in the presence of fenpiverinium in combined suppository dosage form.

A new HPLC method for separation and determination of impurities in paracetamol, codeine phosphate hemihydrate and pitophenone hydrochloride in the presence of fenpiverinium bromide in combined suppository dosage form was developed and validated. The separation of paracetamol and its impurities 4-aminophenol, 4-nitrophenol, 4-chloracetanilid; codeine and its impurities methylcodeine, morphine, codeine dimer and 10-hydroxycodeine; pitophenone and its impurities 2-[4-[2-(1-piperidinyl)ethoxy]benzoyl] benzoic acid, 2-[4-[2-(1-piperidinyl)ethoxy]benzoyl]benzoic acid 2-(1-piperidinyl)-ethyl ester, methyl ester of 2-(4-hydroxybenzoyl) benzoic acid and fenpiverinium was achieved by using ion-pair reversed phase liquid chromatography with UV detection. Validation parameters such as the precision, accuracy, linearity, limit of detection (LOD), limit of quantification (LOQ) and robustness were verified for all the mentioned impurities of codeine phosphate hemihydrate and 4-aminophenol and 2-[4-[2-(1-piperidinyl)ethoxy]benzoyl] benzoic acid as the main degradation products of paracetamol and pitophenone hydrochloride, respectively. The described method was found to be useful for analysis of the stability samples and therefore suitable for routine purity testing of the drug product.