Assay of new combination of tamsulosin and tadalafil using synchronous spectrofluorimetric method coupled with mathematical tools.

A fixed-dose combination therapy of tamsulosin andtadalafilis now available for treatmentof lower urinary tract symptoms associated with benign prostatic hyperplasia. The decrease in sexual performance which is a side-effect of tamsulosin can be compensated by using tadalafil. This study is the first to develop and optimize a synchronous spectrofluorimetric method coupled with derivative and derivative ratio mathematical tools for the determination of tamsulosin andtadalafil in their newly released dosage form. The method successed in quantification of tadalafil by measuring the second-order derivative synchronous spectrofluorimetric amplitude at 278 nm (corresponding to zero-crossing of tamsulosin) using Δƛ=11 nm. On the other hand, first derivative ratio synchronous spectrofluorimetric peak amplitude was measured at 260 nm for determination of tamsulosin, using Δƛ=15 nm and divisor concentration of 0.1 µg mL-1. The method validation was performed using ICH guidelines. The linear responses of tamsulosin andtadalafil were from 0.04 to 0.5 and 0.05-0.5 µg mL-1, respectively. High sensitivity was achieved as represented by slope values of 0.32 and 608.4 for tamsulosin andtadalafil, respectively. The method is sensitive enough to detect concentration as low as 0.024 for both drugs. The proposed integrated spectrofluorimetric method showed good simplicity, selectivity and greenness. It can be successfully applied for analysis of both drugs in dosage form.

Topical lidocaine-prilocaine cream versus lidocaine infiltration for pain relief during repair of perineal tears after vaginal delivery: randomized clinical trial.

OBJECTIVE: The current study aims to compare the analgesic effect of lidocaine-prilocaine (LP) cream with lidocaine infiltration during repair of perineal tears after vaginal delivery. MATERIALS AND METHODS: A single center open-labeled randomized clinical trial was carried out in a tertiary University Hospital between October 2016 and May 2017 (Clinical Trials.Gov: NCT02883179). We included parous women, who delivered at gestational age >37 weeks with first- or second-degree perineal tears. The participants were randomized in a 1:1 ratio to either lidocaine infiltration (Group I); or application of LP cream (Group II) for pain relief during perineal repair. The primary outcome was the difference in mean pain score during perineal repair. Secondary outcomes included the participants' satisfaction, the need for additional anesthesia, the duration of perineal repair, and the rate of adverse effects of both medications. RESULTS: The study included 144 participants randomized to both groups. The mean pain score during perineal repair was significantly lower in the LP cream group (3.86 ± 1.59) than the lidocaine infiltration group (5.99 ± 1.47) [p = .001]. The duration of repair was significantly shorter in the LP group than the lidocaine infiltration group (6.37 ± 3.68 versus 8.17 ± 2.75 min, respectively, p = .001). The need for additional anesthesia was quite similar in both groups (p = .371). More women in the LP cream group were satisfied than the other group with statistical significant difference (76.4 versus 30.6%, p = .000). No difference between side effects in both groups (p = .171) Conclusions: Topical application of lidocaine-prilocaine cream is an effective analgesic during repair of perineal tears with no harmful side effects.