Objectives of the study: The aim of this study was to evaluate the biochemical and hematological changes which occur in the serum of pregnant women with pre-eclampsia. Materials and methods: The study included 120 pregnant women with pre-eclampsia, beside 75 normotensive women at third trimester of pregnancy, served as group. Serum uric acid, creatinine, urea, total protein, albumin, alanine amino transferase (AST), as partate amino transferase (ALT), alkaline phosphatase (ALP) were measured using automated chemical analyzer. Serum sodium and potassium were measured using iron selective electron. Complete blood count (CBC) was done using full automated hematology analyzer. Data were analyzed using IBM SPSS Statistics version 20. Results: The study revealed that the mean age of the women with pre-eclampsia was (28.11±6.45years), versus (29.18±6.35 years). The diastolic blood pressure was (152.29±17.67mmHg) versus (106.48±11.54mmHg) with P.value (0.000). The systolic blood was (122.80±5.57mmHg) versus (78.94±3.25mmHg) with P.value (0.000). Serum creatinine was (0.68±0.36mg/dl) versus (0.43±0.25mg/dl) with P.value (0.000). Uric acid was (6.96±2.07 mg/dl) versus (4.98±1.42mg/dl) with P value (0.000). The mean ALP was (130.70±46.12U/L) versus (83.85±17.67U/L) with P. value (0.000). The AST was (63.88±112.23 U/L) versus (29.60±12.07 U/L) with P.value (0.01). The ALT was (32.10±49.91 U/L) versus (18.18±8.55 U/L) with P.value (0.003). The mean of white blood cells (WBCs) was (9.44±4.18x109/l) versus (8.22±2.77x109/l) with P.value (0.015). The mean of platelets (PLTs) was (211.19±93.06x109/l) versus (245.36±65.97x109/l) with P.value (0.003). Conclusion: In Sudanese women with preclampsia; serum creatinine, uric acid, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and white blood cell count significantly increase, while platelets count significantly decrease.
Eltayeb Mohamed Ahmed Tayrab* and Sohinda Saladdin.
A simple, specific, accurate, precise and reproducible method has been developed and validated for the determination of Rifampicin in bulk and capsule by UV spectrophotometric method. This includes the detection of wave length for bulk and marketed at 337 nm. Rifampicin follows the beers law over the concentration range of 5-13µg/ml. The percentage recoveries for both the bulk and marketed capsule were found to be nearly 98-100% representing the accuracy of the proposed methods. Validation of the proposed methods was carried out for its accuracy, precision, and specificity according to ICH guidelines. The proposed and developed method can be successfully applied in routine laboratory analysis for the determination of Rifampicin individually.
A sensitive, simple and accurate stability-indicating HPLC method has been developed and validated for determination of Donepezil hydrochloride (DP) in pure and in tablet dosage form. Chromatographic separation was achieved within 10.0 min on Hypersil column (250 x 4.6 mm, 5 µm particle size) using isocratic method. A mobile phase containing a mixture of acetonitrile and 0.025 M potassium dihydrogen phosphate buffer of pH 3.5 (80:20) was pumped at a flow rate of 1mL/min. The column temperature was maintained at 40°C. The detection wavelength was set at 210 nm. DP was subjected to stress degradation conditions of hydrolysis (acid and base), oxidation, thermal degradation at 80°C for 2 hours and photolytic degradation. The proposed method showed excellent linearity over the range of 0.5 - 100 µg/mL and determination coefficient was 0.9998. Limit of detection was 0.14 µg/ mL and limit of quantification was 0.42µg/mL. This method is capable of complete chromatographic separation of DP peaks from their degradation products generated under various conditions.
Hanna M. Saleh*, Gamal H. Ragab, Alaa S. Amin and Enas S. Kamel.
A simple, sensitive and accurate stability-indicating HPLC method has been developed and validated for determination of valsartan (VAL) and hydrochlorothiazide (HCT) in pure and in combination tablet forms. The Chromatographic separation was achieved within 10.0 min on Hypersil BDS C18column (250 x 4.6 mm, 5 µm particle sizes). The mobile phase contains a mixture of0.05 M phosphate buffer pH 3.5 and acetonitrile in ratio (50: 50). The isocratic RP- HPLC was investigated to separate the drugs from their stressed degradation products. The flow rate was 1mL/min and the column temperature was maintained at 40°C. VAL and HCT were subjected to stress degradation conditions of hydrolysis (acid and base), oxidation, thermal degradation at 80°C for 2 hours and photolytic degradation. Stressed samples were analyzed by the developed procedure. The described method shows excellent linearity over a range of 16.0 – 112.0 µg/mL, 2.5- 17.5 µg/mL for VAL and HCT, respectively and the correlation coefficients was 0.9996 for both VAL and HCT. The limit of detection was 4.6µg/mL and 0.72µg/mL while limit of quantitation was 15.3µg/mL and 2.1µg/mL for VAL and HCT, respectively. The suggested method was successfully applied for the analysis of the two drugs combination in tablet dosage form. The application of the proposed method was extended to stability studies of VAL and HCT after exposure to different forced degradation conditions according to ICH guidelines. Moreover, the method was validated for linearity, accuracy, precision, and robustness.
Gamal H. Ragab*, Hanna M. Saleh, Alaa S. Amin, Enas S. Kamel.
A new reverse phase HPLC method was developed for the simultaneous estimation of verapamil hydrochloride and trandolapril in bulk and pharmaceutical dosage forms. The method was developed and validated using symmetrical C18 column (4.6 x 150mm, 3.5m) at ambient temperature. The mobile phase consisted of potassium dihyrogen ortho phosphate buffer (pH2.2): acetonitrile [35:65 v/v] at a flow rate of 0.6ml /min and UV detection wavelength was at 230 nm. The retention time for verapamil hydrochloride was 2.5min and trandolapril was at 3.8min. The linearity range of verapamil hydrochloride and trandolapril were in the range of 10µg/ml to 65µg/ml and 2µg/ml to15µg/ml respectively. The method was validated as per the ICH guidelines and successfully applied to the marketed product. The method was found to be simple, rapid, precise and accurate.