1.Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study
Shah V. JAIVIK ; Parekh M. JIGNESH ; Shah A. PRIYANKA ; Shah V. PRIYA ; Sanyal MALLIKA ; Shrivastav S. PRANAV
Journal of Pharmaceutical Analysis 2017;7(5):309-316
A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCTZ) in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS). The analytes and their deuterated analogs were quantitatively extracted from 100 μL human plasma by solid phase extraction on Oasis HLB cartridges. The chromatographic separation of the analytes was achieved on a Chromolith RP18e (100 mm × 4.6 mm) analytical column within 2.5 min. The resolution factor between AML and VAL, AML and HCTZ, and VAL and HCTZ was 2.9, 1.5 and 1.4, respectively, under isocratic conditions. The method was validated over a dynamic concentration range of 0.02–20.0 ng/mL for AML, 5.00–10,000 ng/mL for VAL and 0.20–200 ng/mL for HCTZ. Ion-suppression/enhancement effects were investigated by post-column infusion technique. The mean IS-normalized matrix factors for AML, VAL and HCTZ were 0.992, 0.994 and 0.998, respectively. The intra-batch and inter-batch precision (% CV) across quality control levels was ≤ 5.56% and the recovery was in the range of 93.4%–99.6% for all the analytes. The method was successfully applied to a bioequivalence study of 5 mg AML + 160 mg VAL + 12.5 mg HCTZ tablet formulation (test and reference) in 18 healthy Indian males under fasting. The mean log-transformed ratios of Cmax, AUC0–120h and AUC0-inf and their 90% CIs were within 90.2%–102.1%. The assay reproducibility was demonstrated by reanalysis of 90 incurred samples.
2.Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study
Shah V. JAIVIK ; Parekh M. JIGNESH ; Shah A. PRIYANKA ; Shah V. PRIYA ; Sanyal MALLIKA ; Shrivastav S. PRANAV
Journal of Pharmaceutical Analysis 2017;7(5):309-316
A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCTZ) in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS). The analytes and their deuterated analogs were quantitatively extracted from 100 μL human plasma by solid phase extraction on Oasis HLB cartridges. The chromatographic separation of the analytes was achieved on a Chromolith RP18e (100 mm × 4.6 mm) analytical column within 2.5 min. The resolution factor between AML and VAL, AML and HCTZ, and VAL and HCTZ was 2.9, 1.5 and 1.4, respectively, under isocratic conditions. The method was validated over a dynamic concentration range of 0.02–20.0 ng/mL for AML, 5.00–10,000 ng/mL for VAL and 0.20–200 ng/mL for HCTZ. Ion-suppression/enhancement effects were investigated by post-column infusion technique. The mean IS-normalized matrix factors for AML, VAL and HCTZ were 0.992, 0.994 and 0.998, respectively. The intra-batch and inter-batch precision (% CV) across quality control levels was ≤ 5.56% and the recovery was in the range of 93.4%–99.6% for all the analytes. The method was successfully applied to a bioequivalence study of 5 mg AML + 160 mg VAL + 12.5 mg HCTZ tablet formulation (test and reference) in 18 healthy Indian males under fasting. The mean log-transformed ratios of Cmax, AUC0–120h and AUC0-inf and their 90% CIs were within 90.2%–102.1%. The assay reproducibility was demonstrated by reanalysis of 90 incurred samples.
3.Asia-Pacific Menopause Federation Consensus Statement on the Management of Menopause 2024
Seng Bin ANG ; Stella Rizalina Sasha SUGIANTO ; Felicia Clara Jun Hui TAN ; Sonia DAVISON ; Qi YU ; Masakazu TERAUCHI ; Mee-Ran KIM ; Jignesh SHAH ; Shaikh Zinnat Ara NASREEN ; Choon Moy HO ; Enkhee SODNOMDORJ ; Muhammad Fidel Ganis SIREGAR ; Rubina HUSSAIN ; Ma Corazon Zaida NOBLEJAS-GAMILLA ; Yang CHUA ; Yung-Chieh TSAI ; Unnop JAISAMRARN
Journal of Menopausal Medicine 2025;31(1):3-11
Objectives:
This study aimed to achieve expert consensus on menopause management in the Asia-Pacific region, taking into account patient diversity, the latest evidence, and current treatment options.
Methods:
A focused literature search was performed to identify clinical practice statements on menopause management. Menopause experts were nominated by members of the Asia-Pacific Menopause Federation (APMF) society. A modified Delphi methodology, involving iterative rounds of anonymous surveys, was employed until consensus was reached for each statement. Consensus was defined as ≥ 70% of experts voting ‘agree’ or ‘strongly agree’ for a given clinical practice statement.
Results:
A total of 39 participants from 14 different APMF member societies were involved. Eighty-five clinical practice statements reached a consensus. Based on the clinical practice statements, an algorithm was created as a tool to guide clinicians on menopause management. APMF experts agreed that, in addition to vasomotor symptoms, Asian women experiencing somatic or psychological symptoms may also benefit from treatment with menopausal hormone therapy (MHT). MHT should also be considered for the prevention of osteoporosis in asymptomatic peri- and postmenopausal women.
Conclusions
This APMF consensus statement supersedes the previous one published in 2008. It provides guidance to gynecologists, endocrinologists, family physicians, and other healthcare professionals in delivering optimal care to menopausal women in the ethnically and culturally diverse Asia-Pacific region.
4.Asia-Pacific Menopause Federation Consensus Statement on the Management of Menopause 2024
Seng Bin ANG ; Stella Rizalina Sasha SUGIANTO ; Felicia Clara Jun Hui TAN ; Sonia DAVISON ; Qi YU ; Masakazu TERAUCHI ; Mee-Ran KIM ; Jignesh SHAH ; Shaikh Zinnat Ara NASREEN ; Choon Moy HO ; Enkhee SODNOMDORJ ; Muhammad Fidel Ganis SIREGAR ; Rubina HUSSAIN ; Ma Corazon Zaida NOBLEJAS-GAMILLA ; Yang CHUA ; Yung-Chieh TSAI ; Unnop JAISAMRARN
Journal of Menopausal Medicine 2025;31(1):3-11
Objectives:
This study aimed to achieve expert consensus on menopause management in the Asia-Pacific region, taking into account patient diversity, the latest evidence, and current treatment options.
Methods:
A focused literature search was performed to identify clinical practice statements on menopause management. Menopause experts were nominated by members of the Asia-Pacific Menopause Federation (APMF) society. A modified Delphi methodology, involving iterative rounds of anonymous surveys, was employed until consensus was reached for each statement. Consensus was defined as ≥ 70% of experts voting ‘agree’ or ‘strongly agree’ for a given clinical practice statement.
Results:
A total of 39 participants from 14 different APMF member societies were involved. Eighty-five clinical practice statements reached a consensus. Based on the clinical practice statements, an algorithm was created as a tool to guide clinicians on menopause management. APMF experts agreed that, in addition to vasomotor symptoms, Asian women experiencing somatic or psychological symptoms may also benefit from treatment with menopausal hormone therapy (MHT). MHT should also be considered for the prevention of osteoporosis in asymptomatic peri- and postmenopausal women.
Conclusions
This APMF consensus statement supersedes the previous one published in 2008. It provides guidance to gynecologists, endocrinologists, family physicians, and other healthcare professionals in delivering optimal care to menopausal women in the ethnically and culturally diverse Asia-Pacific region.
5.Asia-Pacific Menopause Federation Consensus Statement on the Management of Menopause 2024
Seng Bin ANG ; Stella Rizalina Sasha SUGIANTO ; Felicia Clara Jun Hui TAN ; Sonia DAVISON ; Qi YU ; Masakazu TERAUCHI ; Mee-Ran KIM ; Jignesh SHAH ; Shaikh Zinnat Ara NASREEN ; Choon Moy HO ; Enkhee SODNOMDORJ ; Muhammad Fidel Ganis SIREGAR ; Rubina HUSSAIN ; Ma Corazon Zaida NOBLEJAS-GAMILLA ; Yang CHUA ; Yung-Chieh TSAI ; Unnop JAISAMRARN
Journal of Menopausal Medicine 2025;31(1):3-11
Objectives:
This study aimed to achieve expert consensus on menopause management in the Asia-Pacific region, taking into account patient diversity, the latest evidence, and current treatment options.
Methods:
A focused literature search was performed to identify clinical practice statements on menopause management. Menopause experts were nominated by members of the Asia-Pacific Menopause Federation (APMF) society. A modified Delphi methodology, involving iterative rounds of anonymous surveys, was employed until consensus was reached for each statement. Consensus was defined as ≥ 70% of experts voting ‘agree’ or ‘strongly agree’ for a given clinical practice statement.
Results:
A total of 39 participants from 14 different APMF member societies were involved. Eighty-five clinical practice statements reached a consensus. Based on the clinical practice statements, an algorithm was created as a tool to guide clinicians on menopause management. APMF experts agreed that, in addition to vasomotor symptoms, Asian women experiencing somatic or psychological symptoms may also benefit from treatment with menopausal hormone therapy (MHT). MHT should also be considered for the prevention of osteoporosis in asymptomatic peri- and postmenopausal women.
Conclusions
This APMF consensus statement supersedes the previous one published in 2008. It provides guidance to gynecologists, endocrinologists, family physicians, and other healthcare professionals in delivering optimal care to menopausal women in the ethnically and culturally diverse Asia-Pacific region.