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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 44 M .Pharm. Thesis

Acceptance criteria:

¾ A correlation coefficient (r) of the calibration curve must be > 0.9900.

¾ The back-calculated concentration of the lowest calibration standard (CS1) must be

within 80-120% of its theoretical concentration.

¾ The back-calculated concentrations of all other calibration standards must be within 85-

115% of their theoretical concentrations.

¾ The curve must contain at least 75% of the calibration standards for evaluation of curve

fitting.

¾ No two adjacent (or consecutive) calibration standards can be rejected.

¾ Both replicates each of LLOQ and ULOQ standard cannot be rejected, either of the two

replicate must meet the acceptance criteria.

E. Accuracy:

1. Within-batch or intra-batch accuracy:

¾ Calibration standards and six replicates each of LLOQ, LQC, MQC and HQC samples

were processed and analyzed as per the procedure described in sample preparation

section.

¾ % nominal concentration of back-calculated value for LLOQ, LQC, MQC and HQC,

analyzed in single analytical batch was calculated, as per formula to determine within-

batch or intra-batch accuracy.

2. Between -batch or inter-batch accuracy:

¾ Calibration standards and six replicates each of LLOQ, LQC, MQC and HQC samples

were processed and analyzed as per the procedure described in sample preparation

section.

¾ Five different batches on different days were performed.

¾ % nominal concentration of back-calculated value for LLOQ, LQC, MQC and HQC

samples, analyzed on five different batches on different days was calculated.

Acceptance criteria:

¾ The back calculated concentrations of all QC samples (LQC, MQC, and HQC) must be

within 85-115% of their nominal concentration except at LLOQ sample where it should

not deviate by more than 80-120% of its nominal concentration.

¾ At least 67% quality control samples must fall within above-mentioned criteria at each

LLOQ, LQC, MQC, and HQC levels.

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Samsung RT34M Manuale Utente Pagina 56