A Comparison of the Reliability of the Patellar Tendon-Trochlear Groove (PTTG) Distance and the Tibial Tuberosity-Trochlear Groove (TTTG) Distance Measured on MRI.

INTRODUCTION: An increased tibial tuberosity-trochlear groove (TTTG) distance is used for deciding a treatment plan in patello-femoral instability (PFI). The centre of the patellar tendon and the chondral trochlear groove can be directly visualised on MRI, and measured, giving the patellar tendon-trochlear groove (PTTG) distance. A study was designed to compare the inter-rater and the test-retest reliabilities of PTTG and TTTG measurements in MRI of patients without PFI and in a group with PFI. MATERIALS AND METHODS: This cross-sectional reliability study was done on archival MRI films of 50 patients without patellar instability and 20 patients with patellar instability. TTTG and PTTG distances were independently measured by two orthopaedic surgeons and two radiologists. A hybrid PTTG measurement with bony landmarks on the femoral side and the patellar tendon landmark on the tibial side, was used to estimate the influence of the differences in the femoral and tibial landmarks on the difference in reliabilities. The intra-class correlation coefficient (ICC) was calculated for all four raters, as well as separately for each rater. RESULTS: The PTTG distance had a higher inter-rater reliability (ICC=0.86, 95% CI=0.79-0.92) compared to the TTTG distance (ICC=0.70, 95% CI=0.59-0.80) in patients without PFI. Similar trends were seen in patients with PFI (0.83 vs 0.66). The inter-rater reliability for the hybrid PTTG distance was found to lie in between the TTTG and PTTG. CONCLUSIONS: The MRI-based PTTG distance had better inter-rater reliability compared with the MRI-based TTTG distance.

A rapid and sensitive LC-MS/MS assay for the determination of saxagliptin and its active metabolite 5-hydroxy saxagliptin in human plasma and its application to a pharmacokinetic study.

The authors proposed a simple, rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method for the simultaneous determination of saxagliptin and its active metabolite 5-hydroxy saxagliptin in human plasma. The developed method was fully validated as per the US FDA guidelines. The method utilized stable labeled isotopes saxagliptin-15 N d2 (IS1) and 5-hydroxy saxagliptin-15 N-d2 (IS2) as internal standards for the quantification of saxagliptin and 5-hydroxy saxagliptin, respectively. Analytes and the internal standards were extracted from human plasma by a single step solid-phase extraction technique without drying, evaporation and reconstitution steps. The optimized mobile phase was composed of 0.1% acetic acid in 5 mM ammonium acetate and acetonitrile (30:70, v/v) and delivered at a flow rate of 0.85 mL/min. The method exhibits the linear calibration range of 0.05-100 ng/mL for both the analytes. The precision and accuracy results for both the analytes were well within the acceptance limits. The different stability experiments conducted in aqueous samples and in matrix samples are meeting the acceptance criteria. The chromatographic run time was set at 1.8 min; hence more than 400 samples can be analyzed in a single day.

A simple, rapid and sensitive UFLC-MS/MS method for the quantification of oral contraceptive norgestrel in human plasma and its pharmacokinetic applications.

A simple, rapid and sensitive ultra flow liquid chromatography-tandem mass spectrometry (UFLC-MS/MS) assay for the determination of norgestrel in human plasma was developed using levonorgestrel D6 as an internal standard (IS). Norgestrel and IS were extracted from human plasma via liquid-liquid extraction. Chromatographic separation was achieved on a Zorbax XDB-Phenyl column under isocratic conditions. Detection was done by tandem mass spectrometry, operating in positive ion mode. The protonated precursor to product ion transitions monitored for norgestrel and IS were at m/z 313.30→245.40 and 319.00→251.30 respectively. The method was fully validated as per current regulatory guidelines. Anticoagulant counter ion effect was also assessed with K2EDTA and K3EDTA. The method was validated with a linearity range of 304.356-50 807.337 pg/mL having run time of 2.0 min per sample. The method has shown tremendous reproducibility with intra- and inter-day precision (%CV) less than 11.0% and intra- and inter-day accuracy less than 9.0% of nominal values. The validated method was applied to a pharmacokinetic study in human plasma samples generated after administrating a single oral dose of 0.3 mg norgestrel tablets to healthy female volunteers and has proved to be highly reliable for the analysis of clinical samples.